Status:
WITHDRAWN
Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19
Lead Sponsor:
Heinrich-Heine University, Duesseldorf
Collaborating Sponsors:
Universitätsklinikum Hamburg-Eppendorf
Goethe University
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 object...
Detailed Description
The ongoing pandemic with the novel coronavirus (SARS-CoV-2) poses a massive threat to public health. SARS-CoV-2 is highly contagious and may lead to severe acute respiratory distress syndrome in affe...
Eligibility Criteria
Inclusion
- 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
- 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- Concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration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:
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04338906
Start Date
May 1 2020
End Date
December 1 2021
Last Update
December 21 2020
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