- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05261139
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study treatment works in the study) of the study medicine (called nirmatrelvir/ritonavir) for potential treatment of coronavirus disease 2019 (COVID-19).
The study medicine will be given to patients under 18 years of age with COVID-19 that are not hospitalized but are at risk for severe disease.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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Gorna Oryahovitsa, Bulgaria, 5100
- МHAT "Sveti Ivan Rilski" Gorna Oryahovitsa
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Lom, Bulgaria, 3600
- Diagnostic-Consultative Center I Lom EOOD
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Plovdiv, Bulgaria, 4000
- DCC Sveti Georgi EOOD
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Ruse, Bulgaria, 7002
- "Specialized Hospital for Active Treatment of Pneumo-Physiatric Diseases Dr. Dimitar Gramatikov -
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Sevlievo, Bulgaria, 5400
- Medical Center-1-Sevlievo EOOD
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Sofia, Bulgaria, 1431
- DCC "Alexandrovska"
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Vratsa, Bulgaria, 3000
- Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases Vratsa EOOD
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Debrecen, Hungary, 04032
- Debreceni Egyetem Klinikai Kozpont
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Debrecen, Hungary, 4031
- Debreceni Egyetem Klinikai Kozpont
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Heves
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Eger, Heves, Hungary, 3300
- Markhot Ferenc Oktatokorhaz es Rendelointezet
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Aguascalientes, Mexico, 20259
- Centenario Hospital Miguel Hidalgo
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Veracruz, Mexico, 91900
- Sociedad de Metabolismo y Corazon
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Veracruz, Mexico, C.P. 91900
- Sociedad de Metabolismo y Corazon S.C.
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Veracruz, Mexico, 91910
- Arké SMO S.A de C.V
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Distrito Federal
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Mexico City, Distrito Federal, Mexico, 04530
- Instituto Nacional de Pediatria
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Mexico City, Distrito Federal, Mexico, 06720
- Hospital Infantil de Mexico Federico Gomez
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Morelos
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Cuernavaca, Morelos, Mexico, 62290
- JM Research SC
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Nuevo LEON
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Monterrey, Nuevo LEON, Mexico, 64718
- Eukarya Pharmasite S.C.
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Nuevo LEÓN
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Monterrey, Nuevo LEÓN, Mexico, 64710
- Tecnologico de Monterrey
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Yucatan
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Merida, Yucatan, Mexico, 97070
- Kohler & Milstein Research S.A. De C.V.
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Yucatán
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Merida, Yucatán, Mexico, 97130
- Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan
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Mérida, Yucatán, Mexico, 97000
- Unidad de Atencion Medica e Investigacion en Salud
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Trujillo Alto, Puerto Rico, 00976
- San Miguel Medical
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Gauteng
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Benoni, Gauteng, South Africa, 1500
- Worthwhile Clinical Trials
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Germiston, Gauteng, South Africa, 1401
- CRISMO Research Centre
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Pretoria, Gauteng, South Africa, 0184
- Botho Ke Bontle Health Services
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Limpopo
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Dennilton, Limpopo, South Africa, 0470
- Ndlovu Research Centre
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Thabazimbi, Limpopo, South Africa, 0380
- Limpopo Clinical Research Initiative
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London, United Kingdom, W2 1NY
- Imperial College Healthcare NHS Trust
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Manchester, United Kingdom, M13 9WL
- Royal Manchester Children's Hospital
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England
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London, England, United Kingdom, SW17 0QT
- St. George's Hospital
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London, CITY OF
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London, London, CITY OF, United Kingdom, NW1 2PG
- University College London Hospital
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London, London, CITY OF, United Kingdom, SE5 9RL
- King's College Hospital
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham - School of Medicine
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Arizona
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Phoenix, Arizona, United States, 85016
- Phoenix Children's Hospital
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Arkansas Children's Hospital
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Los Angeles, California, United States, 90095
- UCLA
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Los Angeles, California, United States, 90027
- Kaiser Permanente
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Orange, California, United States, 92868
- Children's Hospital of Orange County
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Connecticut
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Hartford, Connecticut, United States, 06106
- Connecticut Children's Medical Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- Children's National Medical Center
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Florida
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Miami, Florida, United States, 33130
- Life Spring Research Foundation
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Winter Park, Florida, United States, 32789
- Clinical Site Partners, Inc.
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Georgia
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Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta - Egleston Hospital
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Union City, Georgia, United States, 30291
- SKY Clinical Research Network Group-Blake
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Union City, Georgia, United States, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Illinois
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Chicago, Illinois, United States, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, United States, 60637
- University of Chicago Medical Center
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Kentucky
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Louisville, Kentucky, United States, 40202
- Novak Center for Children's Health
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Louisville, Kentucky, United States, 40202
- Norton Children´s Hospital
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Louisiana
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Shreveport, Louisiana, United States, 71101
- Louisiana State University Health Sciences Shreveport
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Chan Medical School
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne Pediatrics
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Minnesota
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Minneapolis, Minnesota, United States, 55404
- Childrens Hospitals and Clinics of Minnesota
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Mississippi
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Ridgeland, Mississippi, United States, 39157
- SKY Clinical Research Network Group-Quinn
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Ridgeland, Mississippi, United States, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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Saint Louis, Missouri, United States, 63110
- St. Louis Children's Hospital
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Nebraska
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Omaha, Nebraska, United States, 68114
- Children's Hospital & Medical Center
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New Jersey
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Hackensack, New Jersey, United States, 07601
- Hackensack University Medical Center
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New Brunswick, New Jersey, United States, 08901
- Rutgers University
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- University of New Mexico Clinical and Translational Science Center
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Albuquerque, New Mexico, United States, 87102
- University of New Mexico Hospital, COVID-19 Research Clinic
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New York
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Buffalo, New York, United States, 14203
- SUNY University at Buffalo
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Commack, New York, United States, 11725
- Advanced Specialty Care
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East Setauket, New York, United States, 11733
- Stony Brook Medicine Clinical Research Center
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New Hyde Park, New York, United States, 11040
- Cohen Children's Medical Center
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Stony Brook, New York, United States, 11794-8111
- Stony Brook University
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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Syracuse, New York, United States, 13210
- Upstate Golisano Children's Hospital
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Syracuse, New York, United States, 13202
- Upstate Health Care Center
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Syracuse, New York, United States, 13210
- Crouse Physicians Office Building
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina Medical Center
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Chapel Hill, North Carolina, United States, 27514
- UNC Children's Hospital
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Chapel Hill, North Carolina, United States, 27514
- Clinical and Translational Research Center
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Chapel Hill, North Carolina, United States, 27514
- investigational Drug Services Pharmacy, UNC Hospitals
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Chapel Hill, North Carolina, United States, 27514
- UNC Global Clinical Research North
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Durham, North Carolina, United States, 27705
- Duke Vaccine and Trials Unit
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Durham, North Carolina, United States, 27710
- Duke University - Main Hospital and Clinics
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Raleigh, North Carolina, United States, 27607
- UNC Children's Raleigh
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center
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Mayfield Heights, Ohio, United States, 44124
- UH Landerbrook Health Center
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Parma, Ohio, United States, 44129
- UH Parma Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104-4637
- Oklahoma Childrens Hospital at OU Health
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Oklahoma City, Oklahoma, United States, 73104-5008
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Providence, Rhode Island, United States, 02904
- The Miriam Hospital-Clinical Trials
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South Carolina
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Summerville, South Carolina, United States, 29486
- Coastal Pediatric Research
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Avera McKennan Hospital & University Health Center
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Sioux Falls, South Dakota, United States, 57108
- Avera Research Institute - Sioux Falls
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Tennessee
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Memphis, Tennessee, United States, 38103
- Le Bonheur Children's Hospital
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Memphis, Tennessee, United States, 38105
- Le Bonheur Children's Hospital
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Texas
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Houston, Texas, United States, 77030
- Texas Children's Hospital
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McAllen, Texas, United States, 78503
- Biopharma Informatic, LLC
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Shavano Park, Texas, United States, 78231
- Consano Clinical Research, LLC
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Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
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Virginia
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Norfolk, Virginia, United States, 23507
- Childrens Hospital of The Kings Daughters
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Male and female, age 0 to < 18 years, able to swallow for some participants
- Confirmed SARS-CoV-2 infection within 72 hours prior to enrollment
- Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of enrollment and at least 1 of the specified COVID-19 signs/symptoms present at enrollment
- Has at least 1 characteristic or underlying medical condition associated with an increased risk of developing severe illness from COVID-19
Exclusion Criteria:
- History of or need for hospitalization for the medical treatment of COVID-19
- Total bilirubin >=2X upper limit of normal (ULN) (except for Gilbert's syndrome)
- Receiving dialysis or have known moderate to severe renal impairment
- Suspected or confirmed concurrent active systemic infection other than COVID-19
- History of hypersensitivity or other contraindication to any of the components of the study intervention
- Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance or strong inducers of cytochrome P450 (CYP)3A4
- Has received or is expected to receive antibody treatment, antiviral treatment or convalescent COVID-19 plasma
- Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19 through the study follow up
- Females who are pregnant or breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 3 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥2 to <6 years |
PF-07321332
ritonavir
|
Experimental: Cohort 1 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given by tablets or powder by mouth twice a day for 5 days (10 doses total). Weight ≥40 kg
|
PF-07321332
ritonavir
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Experimental: Cohort 2 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will be given as powder by mouth twice a day for 5 days (10 doses total) Weight ≥20 to <40 kg, ≥6 to <18 years
|
PF-07321332
ritonavir
|
Experimental: Cohort 4 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir ≥1 month (≥28 days) to <2 years |
PF-07321332
ritonavir
|
Experimental: Cohort 5 nirmatrelvir/ritonavir
nirmatrelvir/ritonavir <1 month (<28 days) old
|
PF-07321332
ritonavir
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort 1-2: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
|
Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2). Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants. |
Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
|
Cohort 1-2: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
|
Pharmacokinetic (PK) sample(s) for Cohorts 1-2 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (10 to 13 total PK samples for Cohort 1 and 10 samples for Cohort 2). Day 1: 1 hour-post dose by Tasso device and venous blood Day 4: pre-dose (Tasso) Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post AM dose (Tasso); for Cohort 1 pre-dose, and 1, 2 hours post AM dose venous samples in approximately 10 participants. |
Day 1: 1 hour-post dose; Day 4: pre-dose; Day 5: pre-dose, and 1, 2, 4, 6, 8 and 10 hours post dose
|
Cohort 3: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
|
PK sample(s) Cohort 3 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples) Day 1: 1 hour-post dose Tasso and venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso) |
Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
|
Cohort 3: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
|
PK sample(s) Cohort 3 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (7 total samples) Day 1: 1 hour-post dose Tasso and venous blood. Day 2: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 3: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 4: between 2-8 hours post AM dose prior to PM dose (Tasso) Day 5: PK pre-dose and post-dose between 1 to 3 hours (Tasso) |
Day 1: 1 hour-post dose; Day 2: 2-8 hours post dose; Day 3: 2-8 hours post dose; Day 4: 2-8 hours post dose; Day 5: PK pre-dose and post-dose 1 to 3 hours
|
Cohort 4-5: Maximum Observed Plasma Concentration (Cmax) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
|
PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples) Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso) |
Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
|
Cohort 4-5: Area Under the Curve to the End of the Dosing Period (AUC0-tau) of nirmatrelvir and ritonavir
Time Frame: Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
|
PK sample(s) Cohorts 4-5 will be collected by Tasso micro-sampling device and venous blood sample at the following timepoints: (4 total samples) Day 1: 1 hour-post dose Tasso and 1 venous blood. Day 5: PK pre-dose and post-dose AM between 3 to 5 hours (Tasso) |
Day 1: 1 hour-post dose; Day 5: PK pre-dose and post-dose AM between 1 to 3 hours
|
Incidence of Treatment Emergent Adverse Events (TEAEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
|
From Baseline up through Day 34
|
|
Incidence of Serious Adverse Events (SAEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
|
From Baseline up through Day 34
|
|
Incidence of Adverse Events (AEs) leading to discontinuations.
Time Frame: From Baseline up through Day 34
|
From Baseline up through Day 34
|
|
Number of participants with change from Baseline in Vital Signs
Time Frame: From Baseline up through Day 34
|
From Baseline up through Day 34
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with COVID-19 related hospitalization or death from any cause
Time Frame: From Baseline through Day 28
|
To evaluate the efficacy of nirmatrelvir/ritonavir for the treatment of COVID-19 in nonhospitalized symptomatic pediatric participants with COVID-19 who are at increased risk of progression to severe disease.
|
From Baseline through Day 28
|
Viral load assessment titers measured via reverse transcription polymerase chain reaction (RT-PCR) in nasopharyngeal or nasal swabs over time
Time Frame: Baseline, Day 4, 5, 6, 10, 14 and 28
|
To evaluate the change in viral loads in pediatric participants from birth to <18 years of age with COVID-19 who are at risk of progression to severe disease.
|
Baseline, Day 4, 5, 6, 10, 14 and 28
|
Patient assessment on acceptability and palatability of nirmatrelvir/ritonavir (film-coated tablets and oral powder)
Time Frame: At baseline only for tablets and after each dose for powder formulation
|
Frequency of responses to visual questionnaire on taste.
|
At baseline only for tablets and after each dose for powder formulation
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Pneumonia
- Lung Diseases
- COVID-19
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Protease Inhibitors
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- HIV Protease Inhibitors
- Viral Protease Inhibitors
- Ritonavir
- Nirmatrelvir
Other Study ID Numbers
- C4671026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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