Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals (RES-Q-HR)

February 9, 2022 updated by: Heinrich-Heine University, Duesseldorf

Reconvalescent Plasma / Camostat Mesylate Early in Sars-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals

This study is a 4-arm, multicenter, randomized, partly double- blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. The working hypothesis to be tested in the RES-Q-HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression. The primary endpoint of the study is the cumulative number of individuals who progressed to or beyond category 4b on the modified WHO (World Health Organization) COVID-19 ordinal scale within 28 days after randomization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The novel coronavirus designated SARS CoV-2, and the disease caused by this virus designated COVID-19. No treatment is available for early disease stages and non-hospitalized patients to date. This trial focusses on SARS-CoV-2 positive patients with pre-existing risk factors for a moderate or severe COVID-19 disease course. This study is a 4-arm, multicenter, randomized, partly double-blind, controlled trial to evaluate the safety and efficacy of convalescent serum (CP) or camostat mesylate with control or placebo in adult patients diagnosed with SARS-CoV-2 and high risk for moderate/severe COVID-19. Camostat mesylate acts as an inhibitor of the host cell serine protease TMPRSS2 and prevents the virus from entering the cell. Convalescent plasma (CP) represents another antiviral strategy in terms of passive immunization. The working hypothesis to be tested in the RES-Q HR study is that the early use of convalescent plasma (CP) or camostat mesylate (Foipan®) reduces the likelihood of disease progression to modified WHO stages 4b-8 in SARS-CoV-2 positive adult patients at high risk of moderate or severe COVID-19 progression.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
        • Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg
    • Bavaria
      • München, Bavaria, Germany, 81675
        • Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60590
        • Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV
    • North Rhine Westphalia
      • Duesseldorf, North Rhine Westphalia, Germany, 40225
        • Universitätsklinikum Düsseldorf Klinik für Hepatologie und Infektiologie
    • North Rhine-Westphalia
      • Dortmund, North Rhine-Westphalia, Germany, 44137
        • Klinikum Dortmund
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitatsklinikum Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Individuals (female, male, diverse) ≥ 18 years with SARS-CoV-2 infection, confirmed by PCR before study enrollment
  2. SARS-CoV-2 positive PCR ≤ 3 days old (date of NP swab)
  3. Presence of ≥ 1 SARS-CoV-2 typical symptom (fever, cough, shortness of breath, sore throat, headache, fatigue, smell/and or taste disorder, diarrhea, abdominal symptoms, exanthema) and symptom duration <= 3 days.
  4. Ability to provide written informed consent

  5. Presence of at least one of the following criteria:

    • Patients > 75 years
    • Patients > 65 years with at least one other risk factor (BMI >35 kg/m2, coronary artery disease, chronic kidney disease (CKD) with glomerular filtration rate (GFR) <60 ml/min but >= 30 ml/min, diabetes mellitus, active tumor disease)
    • Patients with a BMI >35 kg/m2 with at least one other risk factor (CAD, CKD with GFR <60 ml/min but >= 30 ml/min, diabetes mellitus, active tumor disease)
    • Patients with a BMI >40 kg/m2
    • Patients with chronic obstructive pulmonary disease (COPD) and/or pulmonary fibrosis

Exclusion Criteria:

  1. Age <18 years
  2. Unable to give informed consent
  3. Pregnant women or breast-feeding mothers
  4. Previous transfusion reaction or other contraindication to a plasma transfusion
  5. Known hypersensitivity to camostat mesylate and/or severe pancreatitis
  6. Volume stress due to CP administration would be intolerable
  7. Known IgA deficiency
  8. Life expectancy < 6 months
  9. Duration SARS-CoV-2 typical symptoms > 3 days
  10. SARS-CoV-2 PCR detection older than 3 days
  11. SARS-CoV-2 associated clinical condition >= WHO stage 3 (patients hospitalized for other reasons than COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria).
  12. Previously or currently hospitalized due to SARS-CoV-2
  13. Previous antiviral therapy for SARS-CoV-2
  14. alanine aminotransferase (ALT) or aspartate transferase (AST) > 5 times upper limit of normal (ULN) at screening
  15. Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from the trial)
  16. Chronic kidney disease with GFR < 30 ml/min
  17. Concurrent or planned anticancer treatment during trial period
  18. Accommodation in an institution due to legal orders (§40(4) AMG).
  19. Any psycho-social condition hampering compliance with the study protocol.
  20. Evidence of current drug or alcohol abuse.
  21. Use of other investigational treatment within 5 half-lives of enrollment is prohibited
  22. Previous use of convalescent plasma for COVID-19
  23. Concomitant proven influenza A infection
  24. Patients with organ or bone marrow transplant in the three months prior to Screening Visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: convalescent plasma (CP)
Administration of 2 units of CP (neutralizing anti-SARS-CoV-2 antibody titer of at least 1:160) on day 1
Biological: Convalescent plasma
transfusion of convalescent plasma (CP) with neutralizing antibodies against anti-SARS-CoV-2 ((titer of at least 1:160)
OTHER: Standard of Care
Standard of care allowed
Other: Standard of Care (SoC)
Control Arm for convalescent plasma (CP)
EXPERIMENTAL: Camostat Mesilate
Tablets 600 mg per day in 3 doses over 7 days
Drug: Camostat Mesilate
Tablets over 7 days, daily dose of 600 mg split into 3 doses
PLACEBO_COMPARATOR: Placebo camostat
Placebo Tablets in 3 doses over 7 days (blinded)
Drug: Placebo for Camostat Mesilate
Placebo Tablets over 7 days, split into 3 doses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
WHO ordinal Covid-19 scale up to day 28
Time Frame: up to and including day 28
The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale ≥ 4b up to and including day 28
up to and including day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cumulative number WHO categories 4b-8
Time Frame: day 8, day 14, day 56 and day 90
Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 4b-8
day 8, day 14, day 56 and day 90
Cumulative number WHO categories 3-4a
Time Frame: day 8, day 14, day 28, day 56 and day 90
Cumulative number of persons in the respective treatment arms versus SoC/placebo in WHO categories 3-4a
day 8, day 14, day 28, day 56 and day 90
Not hospitalized
Time Frame: at day 90
Cumulative number of participants not hospitalized at day 90
at day 90
All-cause mortality
Time Frame: at day 90
All-cause mortality at day 90
at day 90
Reinfection
Time Frame: up to day 90
Number of patient with SARS-CoV-2 reinfection up to day 90
up to day 90
Secondary sclerosing cholangitis (SSC)
Time Frame: at day 90
Number of patient with secondary sclerosis cholangitis at day 90
at day 90
chronic pulmonary disease as sequelae from COVID-19
Time Frame: at day 90
Number of patient with COVID-19 associated chronic pulmonary disease
at day 90
patients with remdesivir treatment
Time Frame: up to day 90
The proportion of patients with remdesivir therapy
up to day 90
COVID-19 WHO status of patients at start of remdesivir treatment
Time Frame: up to day 90
The clinical status on the WHO COVID-19 ordinal scale of at the start of remdesivir treatment WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
up to day 90
patients with dexamethasone treatment
Time Frame: up to day 90
The proportion of patients on dexamethasone therapy
up to day 90
COVID-19 WHO status of patients at start of dexamethasone treatment
Time Frame: up to day 90

The clinical status on the WHO COVID-19 ordinal scale of at the start of dexamethasone treatment

WHO ordinal scale ranges from 0 to 8; whereas 0 = no COVID-19 infection and 8 = death
up to day 90
resolution of COVID-19 symptoms
Time Frame: until day of resolution up to day 90
Time to resolution of COVID-19 related symptoms (e.g. fever)
until day of resolution up to day 90
negative SARS-CoV-2-PCR test
Time Frame: until day of first negative test up to day 90
Time to first negative SARS-CoV-2-PCR (polymerase chain reaction)
until day of first negative test up to day 90
Oxygen therapy
Time Frame: number of days with oxygen therapy up to day 90
Duration of oxygen therapy (in days)
number of days with oxygen therapy up to day 90
COVID-19 pneumonia
Time Frame: up to day 90
Frequency of occurrence of COVID-19 pneumonia
up to day 90
Percentage of participants requiring mechanical ventilation
Time Frame: up to day 90
Percentage of participants in each group with need for mechanical ventilation
up to day 90
Number of ventilation days per participant up to day 90
Time Frame: up to day 90
Number of ventilation days per participant up to day 90
up to day 90
hospital stay and intensive care
Time Frame: up to day 90
Duration of hospital stay (in days), duration in intensive care/intermediate care (IMC) (in days)
up to day 90
Mortality
Time Frame: at day 28
All-cause mortality at day 28
at day 28
SAEs
Time Frame: up to day 90
Cumulative incidence of Serious Adverse Events (SAE) per group within 90 days follow up
up to day 90
Grade 3/4 AEs
Time Frame: up to day 90
Cumulative incidence of grade 3/4 Adverse Events (AE) per group
up to day 90
SARS-CoV-2 antibody IgA concentrations
Time Frame: on day 8, day 14, day 90
SARS-CoV-2 antibody concentrations (IgA in g/l) in serum on day 8, day 14, day 90
on day 8, day 14, day 90
SARS-CoV-2 antibody IgG concentrations
Time Frame: on day 8, day 14, day 90
SARS-CoV-2 antibody concentrations (IgG in g/l) in serum on day 8, day 14, day 90
on day 8, day 14, day 90
SARS-CoV-2 neutralizing antibody titers
Time Frame: on day 8, day 14, day 90
SARS-CoV-2 neutralizing antibody titers in serum on day 8, day 14, day 90
on day 8, day 14, day 90
Plasma treatment screening failures
Time Frame: up to day 8 (End of treatment)
Number of screening failures due to the lack of a suitable plasma preparation
up to day 8 (End of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heinrich-Heine University, Duesseldorf

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Verena Keitel-Anselmino, Prof.Dr.med., Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 29, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 29, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RES-Q-HR
  • 2020-004695-18 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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