Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19

• Status: Withdrawn
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Hospital Schwabing Munich, Germany; Missioklinik, Wuerzburg, Germany; St. Georg Hospital Leipzig, Germany; Universitätsklinikum Hamburg-Eppendorf; University Hospital, Frankfurt
• Treatments: Camostat; Gabexate; Hydroxychloroquine

Criteria

Inclusion Criteria:

• Participants ≥18 years of age with SARS-CoV-2 infection confirmed by PCR before randomization

• Willing and able to provide written informed consent

• Hospitalized and requiring medical care for COVID-19, (status 3 or 4 of 7-point ordinal clinical status scale)

• SpO2 ≥93% on room air

• Evidence of pulmonary infiltrate on chest X ray/and or CT scan

Exclusion Criteria:

• Age <18 years old

• Pregnant or breast feeding

• Inability to take oral medication

• Inability to provide informed written consent

• Known hypersensitivity towards 4-aminoquinolines, e.g. hydroxychloroquine and/or camostat

• Use of hydroxychloroquine, chloroquine and or camostat within 6 months prior to baseline

• Patients with known retinopathy or macular degeneration Patients with known glucose-6-phosphate dehydrogenase (G6PD) deficiency

• Prolonged QTc-interval in baseline ECG (>500 ms)

• Concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration

• Major comorbidities, possibly leading to increased unwanted side effects of study drugs: