Combination Therapy With Camostat Mesilate + Hydroxychloroquine for COVID-19

NCT04338906 | Withdrawn Phase 4 DMC

• 1 other identifier: CLOCC-2020
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

COVID

Keywords

Camostat; Hydroxychloroquine; Moderate COVID-10

Outcome Measures

Primary Outcomes (1)

• Not hospitalized

  day 14 from baseline

Secondary Outcomes (10)

• Time to improvement of 2 categories from admission on a 7-point ordinal scale

  day 14

• Proportion of participants in each group with normalization of fever

  day 7 and day 14

• Proportion of participants in each group with oxygen saturation > 94% on room air for >24h

  day 7 and day 14

• Time to fever normalization (if febrile at baseline)

  within 14 days

• Time to first negative SARS-CoV-2 PCR in NP swap (if pos. at baseline)

  within 14 days

Study Arms (2)

Camostat + Hydroxychloroquine

EXPERIMENTAL

Subjects will receive Camostat (400 mg tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7)

Drug: Camostat Mesilate; Drug: Hydroxychloroquine

Placebo + Hydroxychloroquine

ACTIVE COMPARATOR

Subjects will receive placebo (tid) + hydroxychloroquine (400 mg bid day1, 200 mg bid d2-d7)

Drug: Placebo; Drug: Hydroxychloroquine

Interventions

Camostat Mesilate DRUG

400 mg tid, d1-d7

Camostat + Hydroxychloroquine

Placebo DRUG

Instead of Camostat Mesilate, tid, d1-d7

Placebo + Hydroxychloroquine

Hydroxychloroquine DRUG

400 mg bid on day 1, 200 mg bid d2-d7

Camostat + Hydroxychloroquine; Placebo + Hydroxychloroquine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Goethe University: collaborator
• St. Georg Hospital Leipzig, Germany: collaborator
• Hospital Schwabing Munich, Germany: collaborator
• Missioklinik, Wuerzburg, Germany: collaborator

MeSH Terms

Interventions

camostat; Hydroxychloroquine

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Evaluation of the efficacy and safety of hydroxychloroquine + camostat combination therapy in comparison to hydroxychloroquine + placebo in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 8, 2020
• Study Start: May 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 3 Months after publication
• Access Criteria: Open