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

Phase 1

• 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: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862; MedDRA version: 23.0Level: LLTClassification code 10084442Term: SARS-CoV-2 PCR test positiveSystem Organ Class: 100000004848; MedDRA version: 23.0Level: LLTClassification code 10084270Term: SARS-CoV-2 acute respiratory diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-004695-18-DE
• Lead Sponsor: Heinrich-Heine-University Düsseldorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 497

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 <60 ml/min but = 30 ml/min,
- diabetes mellitus,
- active tumor disease
-Patients with chronic pulmonary disease, e.g. obstructive pulmonary disease (COPD), pulmonary fibrosis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 398
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 95

Exclusion Criteria

1.Age <18 years
2.Unable to give informed consent
3.Pregnant women or breast-feeding mothers
4.Known hypersensitivity to camostat mesylate and/or severe pancreatitis
5.Life expectancy < 6 months
6.Duration SARS-CoV-2 typical symptoms > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified