Chloroquine Diphosphate in the Prevention of SARS in Covid-19 Infection (CloroCOVID19II)

• ClinicalTrials.gov Identifier: NCT04342650
• Recruitment Status: Completed
• First Posted: April 13, 2020
• Last Update Posted: July 7, 2020
• Sponsor: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• Information provided by (Responsible Party): Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study Description

Brief Summary:

This is a double-blind, randomized, placebo-controlled clinical trial. A total of 210 individuals aged over 18 years old, without a diagnosis of severe respiratory disease, who came to the study site with clinical and radiological suspicion of SARS-CoV2, will be randomized into two treatment groups at a 1:1 ratio to receive a 5-day CQ diphosphate tablets or placebo (tablet without active ingredient produced with the same physical characteristics).

Condition or disease	Intervention/treatment	Phase
COVID-19; SARS-CoV Infection; Severe Acute Respiratory Syndrome (SARS) Pneumonia; Clinical Trial	Drug: Chloroquine Diphosphate; Drug: Placebo oral tablet	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 152 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Phase IIb Study to Evaluate the Efficacy and Safety of Chloroquine Diphosphate in the Treatment of Patients With Comorbidities, Without Severe Acute Respiratory Syndrome, Under the New Coronavirus (SARS-CoV2): a Double-blind, Randomized, Placebo-controlled Clinical Trial
• Actual Study Start Date: April 8, 2020
• Actual Primary Completion Date: May 14, 2020
• Actual Study Completion Date: June 8, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intervention; CQ 450mg twice daily (3 tablets of 150mg, every 12 hours) on day 1, followed by CQ 450mg once daily (3 tablets of 150mg) from D2 to D5. Oral administration.	Drug: Chloroquine Diphosphate; 150mg tablets; Other Name: chloroquine
Placebo Comparator: Placebo; Placebo tables of equal characteristics and duration of treatment.	Drug: Placebo oral tablet; 150mg placebo tablets

Outcome Measures

Primary Outcome Measures :

1. Proportion of patients with onset of severe acute respiratory syndrome (SARS) [ Time Frame: 7 days after randomization ]
   Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

Secondary Outcome Measures :

1. Mortality rate [ Time Frame: after randomization, up to 28 days ]
   Mortality rate between intervention and placebo group on days 7, 14, and 28 after randomization
2. Number of participants in need of intensive care support [ Time Frame: during and after intervention, up to 28 days ]
   Proportion of participants in need and duration of intensive care support after randomization
3. Viral concentration [ Time Frame: After randomization, up to 7 days ]
   Viral load change in blood and oropharyngeal swab samples
4. Cumulative incidence of serious adverse events [ Time Frame: During and after intervention, up to 28 days ]
   Incidence of serious adverse events during and after treatment
5. Cumulative incidence of grade 3 and 4 adverse events [ Time Frame: During and after intervention, up to 28 days ]
   Incidence of grade 3 and 4 adverse events during and after treatment
6. Proportion of patients with discontinued treatment [ Time Frame: after randomization, up to 28 days ]
   proportion of discontinuation or temporary suspension of treatment (for any reason)
7. Incidence of cardiac lesions [ Time Frame: after randomization, up to 120 days ]
   proportion of patients with increased levels of troponin I
8. Incidence of cardiac disfunctions [ Time Frame: after randomization, up to 120 days ]
   proportion and magnitude of QTcF interval increases higher than 500ms
9. Change in respiratory capacity [ Time Frame: Day 120 after randomization ]
   Changes measured on day 120 will be compared to baseline, through spirometry.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
2. Adult aged 18 or over, at the time of inclusion
3. Not having severe acute respiratory syndrome (SARS), that is, not using mechanical ventilation or supplemental oxygen, peripheral oxygen saturation> 94% in room air, and having a respiratory rate below 24 incursions per minute.
4. Patients with comorbidities only, due to the increased risk of developing SARS

Exclusion Criteria:

1. Patients with chronic use of drugs known to prolong QTc interval.

Contacts and Locations

Locations

Brazil

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, Brazil, 69093-415

Sponsors and Collaborators

Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

More Information

• Responsible Party: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
• ClinicalTrials.gov Identifier: NCT04342650
• Other Study ID Numbers: CAAE: 30504220.5.0000.0005
• First Posted: April 13, 2020
• Last Update Posted: July 7, 2020
• Last Verified: July 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: all patient data will be shared after study publication
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: after study publication
• Access Criteria: Upon formal request to researchers.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Infection; Severe Acute Respiratory Syndrome; Pneumonia; Syndrome; Disease; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Chloroquine; Chloroquine diphosphate; Amebicides; Antiprotozoal Agents; Antiparasitic Agents; Anti-Infective Agents; Antimalarials; Antirheumatic Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Filaricides