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

NCT04681430 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-02-10

No results posted yet for this study

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.

Conditions

  • Corona Virus Infection
  • SARS-CoV-2 Infection
  • SARS-CoV-2 PCR Test Positive
  • SARS-CoV-2 Acute Respiratory Disease

Interventions

BIOLOGICAL

Convalescent plasma

transfusion of convalescent plasma (CP) with neutralizing antibodies against anti-SARS-CoV-2 ((titer of at least 1:160)

DRUG

Camostat Mesilate

Tablets over 7 days, daily dose of 600 mg split into 3 doses

DRUG

Placebo for Camostat Mesilate

Placebo Tablets over 7 days, split into 3 doses

OTHER

Standard of Care (SoC)

Control Arm for convalescent plasma (CP)

Sponsors & Collaborators

  • The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)

    collaborator UNKNOWN

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Verena Keitel-Anselmino, Prof.Dr.med. · Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Düsseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-08
Primary Completion
2021-10-29
Completion
2021-10-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04681430 on ClinicalTrials.gov