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Reconvalescent Plasma/Camostat Mesylate Early in SARS-CoV-2 Q-PCR (COVID-19) Positive High-risk Individuals | Clinical Trials | Clareo Health

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

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

NCT04681430•Heinrich-Heine University, Duesseldorf

View on ClinicalTrials.gov

Summary

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+13 more criteria

Locations (6)

Abteilung Infektiologie Klinik für Innere Medizin II Department Innere Medizin Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Klinik und Poliklinik für Innere Medizin II Klinikum rechts der Isar Technische Universität München

München, Bavaria, Germany

Universitätsklinikum Frankfurt Medizinische Klinik 2: Hämatologie, Onkologie, Hämostaseologie, Rheumatologie, Infektiologie/HIV

Frankfurt am Main, Hesse, Germany

Klinikum Dortmund

Dortmund, North Rhine-Westphalia, Germany

Universitätsklinikum Düsseldorf Klinik für Hepatologie und Infektiologie

Düsseldorf, North Rhine-Westphalia, Germany

Universitätsklinikum Essen

Essen, North Rhine-Westphalia, Germany

Key Dates

Start Date

January 8, 2021

Primary Completion Date

October 29, 2021

Completion Date

October 29, 2021

Last Updated

February 10, 2022

Enrollment

ACTUAL participants

Conditions

Corona Virus InfectionSARS-CoV-2 InfectionSARS-CoV-2 PCR Test PositiveSARS-CoV-2 Acute Respiratory Disease

Interventions

Convalescent plasma

BIOLOGICAL

Camostat Mesilate

DRUG

Placebo for Camostat Mesilate

DRUG

Standard of Care (SoC)

OTHER

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Long COVIDSars-CoV-2 Infection+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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