- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04390503
Convalescent Plasma for Early Treatment of COVID-19
26 juni 2022 uppdaterad av: Andrew Eisenberger
A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19
This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment.
Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%).
This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity.
Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease.
Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS).
In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.
Studietyp
Interventionell
Inskrivning (Faktisk)
89
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Rio de Janeiro, Brasilien, 21040-900
- National Institute of Infectious Diseases Evandro Chagas (INI)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Subjects must be 18 years of age or older
- Recent close contact with a person with COVID-19, i.e. last close contact occurred within 7 days of anticipated infusion of study product. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts. This includes healthcare workers at higher risk of developing severe disease.
OR
- Recent self-reported or documented evidence of infection by nasal swab PCR that is positive for SARS-CoV-2, i.e., nasal sample was collected within 7 days or 10 days of anticipated infusion of study product for those who are asymptomatic or symptomatic, respectively.
- Evidence of infection by nasal swab PCR that is positive for SARS-CoV-2 at screening visit.
- May or may not be hospitalized.
No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms (rated by participant as mild and not interfering with normal daily activities) may include:
- Mild rhinorrhea
- Mild sore throat or throat irritation
- Mild nonproductive cough
- Mild fatigue (able to perform Activities of Daily Living (ADLs))
Risk for severe COVID-19 based on a risk score of ≥ 1 Calculated Risk Score of ≥ 1 point, with risk factors based on Center for Disease Control and Prevention (CDC) description
- Age 65-74: 1 point
- Age ≥ 75: 2 points
- Known cardiovascular disease (including hypertension): 1 point
- Diabetes mellitus: 1 point
- Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point
- Morbid obesity: 1 point
- Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count <200 cells/mL).
Exclusion Criteria:
- Receipt of any blood product in past 120 days.
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
- Confirmed or self-reported presumed COVID-19, with symptoms that began more than 5 days prior to enrollment, and SARS-CoV-2 PCR positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening.
- Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening.
- Symptoms consistent with COVID---19 infection that are more than mild at time of screening.
- History of allergic reaction to transfusion blood products
- Inability to complete infusion of the product within 48 hours after randomization.
- Resident of a long term or skilled nursing facility
- Known prior diagnosis of immunoglobulin A (IgA) deficiency
- Oxygen saturation that is < 95% at the screening visit
- On supplemental oxygen at time of enrollment
- Participation in another clinical trial of anti-viral agent(s) for COVID-19
- Receipt of any COVID-19 vaccine, either as part of a clinical research trial or through routine service delivery.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Participants randomized to the experimental arm will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
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Convalescent Plasma that contains antibody titers against SARS-CoV-2.
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Aktiv komparator: Control (albumin 5%)
Participants randomized to the control arm will receive 2 units of 250 mL (500mL total) of albumin (human) 5% infusion.
The albumin will be prepared in bags that are identical to the bags used for plasma.
The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
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Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Rate of Severe Disease
Tidsram: Up to 28 days
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The efficacy of treatment will be determined by rating disease severity on Day 28, or last rating evaluated, using a seven-category severity scale.
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Up to 28 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Rate of measurable anti-SARS-CoV-2 titers
Tidsram: Up to 90 days
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To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).
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Up to 90 days
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Rate of SARS-CoV-2 PCR Positivity
Tidsram: Up to 28 days
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Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
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Up to 28 days
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Duration of SARS-CoV-2 PCR Positivity
Tidsram: Up to 28 days
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Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
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Up to 28 days
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Levels of SARS-CoV-2 RNA
Tidsram: Up to 28 days
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Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)
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Up to 28 days
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Jessica Justman, MD, Columbia University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Cheng Y, Wong R, Soo YO, Wong WS, Lee CK, Ng MH, Chan P, Wong KC, Leung CB, Cheng G. Use of convalescent plasma therapy in SARS patients in Hong Kong. Eur J Clin Microbiol Infect Dis. 2005 Jan;24(1):44-6. doi: 10.1007/s10096-004-1271-9.
- Casadevall A, Dadachova E, Pirofski LA. Passive antibody therapy for infectious diseases. Nat Rev Microbiol. 2004 Sep;2(9):695-703. doi: 10.1038/nrmicro974.
- Casadevall A, Pirofski LA. Antibody-mediated regulation of cellular immunity and the inflammatory response. Trends Immunol. 2003 Sep;24(9):474-8. doi: 10.1016/s1471-4906(03)00228-x. No abstract available.
- Casadevall A, Scharff MD. Serum therapy revisited: animal models of infection and development of passive antibody therapy. Antimicrob Agents Chemother. 1994 Aug;38(8):1695-702. doi: 10.1128/AAC.38.8.1695. No abstract available.
- Arabi YM, Hajeer AH, Luke T, Raviprakash K, Balkhy H, Johani S, Al-Dawood A, Al-Qahtani S, Al-Omari A, Al-Hameed F, Hayden FG, Fowler R, Bouchama A, Shindo N, Al-Khairy K, Carson G, Taha Y, Sadat M, Alahmadi M. Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia. Emerg Infect Dis. 2016 Sep;22(9):1554-61. doi: 10.3201/eid2209.151164.
- Crowe JE Jr, Firestone CY, Murphy BR. Passively acquired antibodies suppress humoral but not cell-mediated immunity in mice immunized with live attenuated respiratory syncytial virus vaccines. J Immunol. 2001 Oct 1;167(7):3910-8. doi: 10.4049/jimmunol.167.7.3910.
- Gunn BM, Yu WH, Karim MM, Brannan JM, Herbert AS, Wec AZ, Halfmann PJ, Fusco ML, Schendel SL, Gangavarapu K, Krause T, Qiu X, He S, Das J, Suscovich TJ, Lai J, Chandran K, Zeitlin L, Crowe JE Jr, Lauffenburger D, Kawaoka Y, Kobinger GP, Andersen KG, Dye JM, Saphire EO, Alter G. A Role for Fc Function in Therapeutic Monoclonal Antibody-Mediated Protection against Ebola Virus. Cell Host Microbe. 2018 Aug 8;24(2):221-233.e5. doi: 10.1016/j.chom.2018.07.009.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
12 mars 2021
Primärt slutförande (Faktisk)
6 januari 2022
Avslutad studie (Faktisk)
6 januari 2022
Studieregistreringsdatum
Först inskickad
14 maj 2020
Först inskickad som uppfyllde QC-kriterierna
14 maj 2020
Första postat (Faktisk)
15 maj 2020
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AAAT0052
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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