Trial Outcomes & Findings for Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID (NCT NCT04349371)

NCT ID: NCT04349371

Last Updated: 2025-02-27

Results Overview

Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR. This is to determine/measure the clinical efficacy of CQ in healthcare workers.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2025-02-27

Participant Flow

The study was terminated before participants could be assigned to any Arm. There were 5 participants who signed informed consent form: 3 participants withdrew, and 2 participants did not proceed due to study termination.

Participant milestones

Participant milestones
Measure
CQ Group
The study was terminated before participants could be assigned to any Arm. Per protocol, participants will receive CQ supply for 3 months.
Placebo Group
The study was terminated before participants could be assigned to any Arm. Per protocol, participants will receive placebo supply for 3 months.
Overall Study
STARTED
0
0
Overall Study
COMPLETED
0
0
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Saved From COVID-19 - Chloroquine (CQ) Prophylaxis for Health Care Workers at Risk for COVID

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Up to 3 months

Population: The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed.

Diagnosis is based on symptoms of COVID-19 and confirmatory anti-COVID antibodies and when available, COVID-19 PCR. This is to determine/measure the clinical efficacy of CQ in healthcare workers.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The study was terminated before participants could be assigned to any Arm. Data was therefore not collected or analyzed.

This is to measure the efficacy of CQ in preventing any infection as defined by seroconversion to positive anti-COVID antibody status. The number of severe illnesses in at risk healthcare workers and patients with adverse events grade 3 or higher and GI intolerance will be tallied.

Outcome measures

Outcome data not reported

Adverse Events

CQ and Placebo Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anca Askanase, MD

Columbia University

Phone: 212-305-0856

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place