NCT04342650

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Apr 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2020

Completed
Last Updated

August 9, 2021

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

April 4, 2020

Last Update Submit

August 2, 2021

Conditions

COVID-19SARS-CoV InfectionSevere Acute Respiratory Syndrome (SARS) PneumoniaClinical Trial

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with onset of severe acute respiratory syndrome (SARS)

    Evaluate if CQ diphosphate prevents the onset of SARS in patients on intervention group through standardized questionnaires.

    7 days after randomization

Secondary Outcomes (9)

  • Mortality rate

    after randomization, up to 28 days

  • Number of participants in need of intensive care support

    during and after intervention, up to 28 days

  • Viral concentration

    After randomization, up to 7 days

  • Cumulative incidence of serious adverse events

    During and after intervention, up to 28 days

  • Cumulative incidence of grade 3 and 4 adverse events

    During and after intervention, up to 28 days

  • +4 more secondary outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo tables of equal characteristics and duration of treatment.

Drug: Placebo oral tablet

Interventions

Chloroquine DiphosphateDRUG

150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).

Also known as: chloroquine
Intervention
Placebo oral tabletDRUG

150mg placebo tablets

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected cases of COVID-19, due to clinical and radiological data, during the epidemic;
  • 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.
  • Patients with comorbidities only, due to the increased risk of developing SARS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz

Manaus, Amazonas, 69093-415, Brazil

Location

MeSH Terms

Conditions

COVID-19Severe Acute Respiratory SyndromePneumonia

Interventions

chloroquine diphosphateChloroquine

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic 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 4, 2020

First Posted

April 13, 2020

Study Start

April 8, 2020

Primary Completion

May 14, 2020

Study Completion

June 8, 2020

Last Updated

August 9, 2021

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

all patient data will be shared after study publication

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
after study publication
Access Criteria
Upon formal request to researchers.

Locations

BR(1)