Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

NCT04340544 | Terminated Phase 2 DMC

• 1 other identifier: COMIHY
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (\>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 \[1\] replication and anecdotal reports from Chinese COVID-19 patients \[2, 3\] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine. The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment

  28±2 days

Secondary Outcomes (2)

• Difference between hydroxychloroquine- and placebotreated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered)

  28±2 days

• All-cause mortality within 28 days

  28±2 days

Other Outcomes (2)

• Proportion of patients with negative COVID-19 PCR test at day 14 in per protocol population as per throat swab

  28±2 days

• Change in COVID-19 virus load from baseline to day 14

  28±2 days

Study Arms (2)

Hydroxychloroquine

EXPERIMENTAL

Hydroxychloroquine 600mg daily for 7 days

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Equivalent number of placebo capsules

Drug: Placebo

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug and seems to be a potential candidate for the treatment of COVID-19 since it is able to block virus infection by increasing the endosomal pH, required for virus/cell fusion, it affects the activation of p38 mitogen-activated protein kinase (MAPK), involved in the replication of HCoV-229E and can interfere with the terminal glycosylation of ACE2, thus inhibiting SARS-CoV-2 infection.

Hydroxychloroquine

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be ≥18 years at the time of signing the informed consent
• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
• Able to adhere to the study visit schedule and other protocol requirements
• Mild COVID-19 with outpatient management as decided by the treating physician
• Early warning score for 2019-nCoV infected patients ≤ 5
• Females of childbearing potential (FCBP1) must agree
• to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe
• to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
• All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment
• All subjects must agree not to share medication

You may not qualify if:

• Requirement for oxygen administration
• Shortness of breath in resting position
• Creatinin \> 2.0 mg/dl
• Women during pregnancy and lactation
• Participation in other clinical trials or observation period of competing trials
• Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)
• History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia
• Use of concomitant medications that prolong the QT/QTc interval
• Physician decision that involvement in the study is not in the patient´s best interest

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• Robert Bosch Medical Center: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• Bernhard Nocht Institute for Tropical Medicine: collaborator

Study Sites (1)

Institute for Tropical Medicine

Tübingen, 72074, Germany

Location

MeSH Terms

Conditions

COVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 9, 2020
• Study Start: April 22, 2020
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: November 2, 2020

Record last verified: 2020-04

Locations

DE (1)