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

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborator: The Federal Ministry of Health, Germany (Bundesministerium für Gesundheit, BMG)
• Treatments: Camostat; Gabexate

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. 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