Reconvalescent plasma/Camostat mesylate early in Sars-CoV-2 Q-PCR positive high risk individuals - RES-Q HR

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004695-18-DE

Enrollment

497

Registered

2020-10-15

Start date

2020-12-02

Completion date

Unknown

Last updated

2021-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 23.0 Level: LLT Classification code 10053983 Term: Corona virus infection System Organ Class: 100000004862 MedDRA version: 23.0 Level: LLT Classification co

Interventions

Trade Name: Camostat mesylate Product Name: Camostat mesylate Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Ora

Eligibility

Sex/Gender

All

Inclusion criteria

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.Ability to provide written informed consent 4.Potassium values between 3.5-4.9 mmol/l 5.Platelets on full blood count must be = 50.000/µl 6.Presence of at least one of the following criteria: - Patients = 55 years - BMI = 35 kg/m2, - coronary artery disease (CAD), - chronic kidney disease (CKD) with GFR =65 years) yes F.1.3.1 Number of subjects for this age range 95

Exclusion criteria

Exclusion criteria: 1.Age 3 days 7.SARS-CoV-2 PCR detection older than 3 days 8.SARS-CoV-2 associated clinical condition = WHO stage 3 (patients hospitalized for other reasons than mAB treatment, pAB-treatment, CP-treatment, social reasons and COVID-19 may be included if they fulfill all inclusion and none of the exclusion criteria) 9.Previously or currently hospitalized due to SARS-CoV-2 10.Previous antiviral therapy for SARS-CoV-2 11.ALT or AST > 5 x ULN at screening 12.Liver cirrhosis > Child A (patients with Child B/C cirrhosis are excluded from the trial) 13.Chronic kidney disease with GFR < 30 ml/min 14.Concurrent or planned anticancer treatment during trial period 15.Accommodation in an institution due to legal orders (§40(4) AMG). 16.Any psycho-social condition hampering compliance with the study protocol. 17.Evidence of current drug or alcohol abuse. 18.Use of other investigational treatment within 5 half-lives of enrollment is prohibited 19.Concomitant proven influenza A infection 20.Patients with organ or bone marrow transplant in the three months prior to Screening Visit

Design outcomes

Primary

Measure	Time frame
Main Objective: The working hypothesis to be tested in the RES-Q HR study is that the early use of camostat mesylate reduces the likelihood of disease progression to modified WHO stages 4-8 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 4 on the modified WHO COVID-19 ordinal scale within 28 days after randomization.;Secondary Objective: % of patients with at least 1 COVID-19-related medically visit (incl. telemedicine/phone) through day 28; Cumulative no. in the SoC+treatment arm vs. SoC+placebo in WHO categories 4-8 by day 8,14,56 & 90; Cumulative no. in the SoC+treatment arm vs. SoC+placebo in WHO categories 3 by day 8,14,28,56 & 90; "Event-free” survival at day 90 & evaluation of all-cause mortality at day 90 using Kaplan-Meier; The proportion of patients with remdesivir therapy & WHO status at initiation of remdesivir; The proportion of patients on dexamethasone therapy & WHO status at baseline dexamethasone; % of patients with novel COVID-19- associated symptoms, Time to resolution of COVID-19 related symptoms; Time to first negative SARS-CoV-2-PCR ; Duration of oxygen therapy (days); % of participants in each group with need for mechanical ventilation (& ventilation days); Duration of hospital stay (days), duration in intensive care (days); All-cause mortality at day 28 SARS-CoV-2 genetic variants;Primary end point(s): The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale = 4 up to and including day 28.;Timepoint(s) of evaluation of this end point: Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO category 3 by day 28	—

Measure

Time frame

Main Objective: The working hypothesis to be tested in the RES-Q HR study is that the early use of camostat mesylate reduces the likelihood of disease progression to modified WHO stages 4-8 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 4 on the modified WHO COVID-19 ordinal scale within 28 days after randomization.;Secondary Objective: % of patients with at least 1 COVID-19-related medically visit (incl. telemedicine/phone) through day 28; Cumulative no. in the SoC+treatment arm vs. SoC+placebo in WHO categories 4-8 by day 8,14,56 & 90; Cumulative no. in the SoC+treatment arm vs. SoC+placebo in WHO categories 3 by day 8,14,28,56 & 90; "Event-free” survival at day 90 & evaluation of all-cause mortality at day 90 using Kaplan-Meier; The proportion of patients with remdesivir therapy & WHO status at initiation of remdesivir; The proportion of patients on dexamethasone therapy & WHO status at baseline dexamethasone; % of patients with novel COVID-19- associated symptoms, Time to resolution of COVID-19 related symptoms; Time to first negative SARS-CoV-2-PCR ; Duration of oxygen therapy (days); % of participants in each group with need for mechanical ventilation (& ventilation days); Duration of hospital stay (days), duration in intensive care (days); All-cause mortality at day 28 SARS-CoV-2 genetic variants;Primary end point(s): The primary endpoint of the study is the number of individuals whose clinical status is on the COVID-19 modified WHO ordinal scale = 4 up to and including day 28.;Timepoint(s) of evaluation of this end point: Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO category 3 by day 28

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Secondary

Measure	Time frame
Secondary end point(s): • Percentage of patients with at least one COVID-19-related medically attended visit through day 28. These include telemedicine/phone visits, in-person physician-visits, emergency department visits, and hospitalization. • Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO categories 4-8 by day 8, day 14, day 56 and day 90 • Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO category 3 by day 8, day 14, day 28, day 56 and day 90 • "Event-free” (not hospitalized, no COVID-19 associated long-term effects such secondary sclerosing cholangitis, pulmonary disease, no reinfection) survival at day 90 and evaluation of all-cause mortality at day 90 using Kaplan-Meier • The proportion of patients with remdesivir therapy and WHO status at initiation of remdesivir • The proportion of patients on dexamethasone therapy and WHO status at baseline dexamethasone • Percentage of patients with novel COVID-19-associated symptoms after enrolment • Time to resolution of COVID-19-related symptoms (e.g. fever) • Time to first negative SARS-CoV-2-PCR • Duration of oxygen therapy (in days) • Frequency of occurrence of COVID-19 pneumonia • Percentage of participants in each group with need for mechanical ventilation (and ventilation days) • Duration of hospital stay (in days), duration in intensive care/IMC (in days) • All-cause mortality at day 28 • Cumulative incidence of SAEs per group within 90 days follow up • Cumulative incidence of grade 3/4 AEs per group • SARS-CoV-2 antibody concentrations (IgA, IgG, NT) in serum on baseline, day 8, day 14, day 90 • SARS-CoV-2 genetic variants (at baseline) and accumulation of variants of concern (VOC) during treatment period (at last positive PCR test) • Change of Quality of life from baseline to day 28, day 90 (VAS, SF-12);Timepoint(s) of evaluation of this end point: Results of study visits day 8, day 14, day 28, day 56 and day 90 after inclusion into the st	—

Measure

Time frame

Secondary end point(s): • Percentage of patients with at least one COVID-19-related medically attended visit through day 28. These include telemedicine/phone visits, in-person physician-visits, emergency department visits, and hospitalization. • Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO categories 4-8 by day 8, day 14, day 56 and day 90 • Cumulative number of persons in the SoC+treatment arm versus SoC+placebo in WHO category 3 by day 8, day 14, day 28, day 56 and day 90 • "Event-free” (not hospitalized, no COVID-19 associated long-term effects such secondary sclerosing cholangitis, pulmonary disease, no reinfection) survival at day 90 and evaluation of all-cause mortality at day 90 using Kaplan-Meier • The proportion of patients with remdesivir therapy and WHO status at initiation of remdesivir • The proportion of patients on dexamethasone therapy and WHO status at baseline dexamethasone • Percentage of patients with novel COVID-19-associated symptoms after enrolment • Time to resolution of COVID-19-related symptoms (e.g. fever) • Time to first negative SARS-CoV-2-PCR • Duration of oxygen therapy (in days) • Frequency of occurrence of COVID-19 pneumonia • Percentage of participants in each group with need for mechanical ventilation (and ventilation days) • Duration of hospital stay (in days), duration in intensive care/IMC (in days) • All-cause mortality at day 28 • Cumulative incidence of SAEs per group within 90 days follow up • Cumulative incidence of grade 3/4 AEs per group • SARS-CoV-2 antibody concentrations (IgA, IgG, NT) in serum on baseline, day 8, day 14, day 90 • SARS-CoV-2 genetic variants (at baseline) and accumulation of variants of concern (VOC) during treatment period (at last positive PCR test) • Change of Quality of life from baseline to day 28, day 90 (VAS, SF-12);Timepoint(s) of evaluation of this end point: Results of study visits day 8, day 14, day 28, day 56 and day 90 after inclusion into the st

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Countries

Germany

Contacts

Public ContactClinic for Gastroenterology, Hepato

University Hospital Center Düsseldorf

verena.keitel@med.uni-duesseldorf.de00492118116330

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026