NCT04421664

Brief Summary

Study Objective: To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3

Geographic Reach
2 countries

8 active sites

Status
terminated

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

Study Start

First participant enrolled

March 25, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2020

Completed
Last Updated

October 15, 2024

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

June 5, 2020

Last Update Submit

October 9, 2024

Conditions

Corona Virus InfectionSARS-CoV InfectionCoronavirus

Keywords

COVID-19SARS-COV-2CoronavirusCorona virus

Outcome Measures

Primary Outcomes (1)

  • Ordinal Scale of COVID19 Disease Severity at 14 days

    Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the percent of participants who fall into each category per arm.

    14 days

Secondary Outcomes (6)

  • Incidence of Hospitalization

    14 days

  • Incidence of COVID-19 related Death

    90 days

  • Incidence of all-cause Death

    90 days

  • Incidence of All-Cause Study Medicine Discontinuation or Withdrawal

    14 days

  • Overall symptom severity at 5 and 14 days

    5 and 14 days

  • +1 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Participants in this arm will receive the study drug, hydroxychloroquine.

Drug: Hydroxychloroquine

Placebo

PLACEBO COMPARATOR

Participants in this arm will receive a placebo treatment.

Drug: Placebo oral tablet

Interventions

HydroxychloroquineDRUG

200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days

Treatment
Placebo oral tabletDRUG

4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days

Placebo

Eligibility Criteria

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

You may qualify if:

  • Age 18 years of age or older AND provision of informed consent
  • WITH
  • Symptomatic COVID-19 disease with confirmed diagnosis with PCR+ SARS-CoV-2 within \<= 4 days of symptoms
  • Healthcare worker with compatible symptoms with exposure to known PCR+ case \<= 14 days (and no available/pending testing for the individual).

You may not qualify if:

  • Current hospitalization
  • Allergy to chloroquine or hydroxychloroquine
  • Severe diarrhea and/or vomiting
  • Significant hepatic impairment defined as known cirrhosis with history of hepatic encephalopathy or ascites.
  • Prior retinal eye disease
  • Concurrent malignancy requiring chemotherapy
  • Known Chronic Kidney disease, Stage 4 or 5 or dialysis.
  • Known glucose-6 phosphate dehydrogenase (G6PD) deficiency.
  • Known ventricular arrythmia, known prolonged QTc interval, or any known episode of sudden cardiac death
  • Known Porphyria
  • Weight \<40 kg
  • Known Pregnancy of Breastfeeding
  • Current use of chloroquine or hydroxychloroquine
  • Current use of Artemether, Dapsone, Lumefantrine or Mefloquine
  • Current use of Cardiac medicines: amiodarone, digoxin, dofetilide, flecainide, procainamide, sotalol, or propafenone
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University of Alberta

Edmonton, Alberta, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Eastern Health

St. John's, Newfoundland and Labrador, Canada

Location

McMaster University

Hamilton, Ontario, Canada

Location

Lawson Health Research Institute

London, Ontario, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A3J1, Canada

Location

Related Publications (3)

  • Skipper CP, Pastick KA, Engen NW, Bangdiwala AS, Abassi M, Lofgren SM, Williams DA, Okafor EC, Pullen MF, Nicol MR, Nascene AA, Hullsiek KH, Cheng MP, Luke D, Lother SA, MacKenzie LJ, Drobot G, Kelly LE, Schwartz IS, Zarychanski R, McDonald EG, Lee TC, Rajasingham R, Boulware DR. Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial. Ann Intern Med. 2020 Oct 20;173(8):623-631. doi: 10.7326/M20-4207. Epub 2020 Jul 16.

    PMID: 32673060BACKGROUND

  • Boulware DR, Pullen MF, Bangdiwala AS, Pastick KA, Lofgren SM, Okafor EC, Skipper CP, Nascene AA, Nicol MR, Abassi M, Engen NW, Cheng MP, LaBar D, Lother SA, MacKenzie LJ, Drobot G, Marten N, Zarychanski R, Kelly LE, Schwartz IS, McDonald EG, Rajasingham R, Lee TC, Hullsiek KH. A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19. N Engl J Med. 2020 Aug 6;383(6):517-525. doi: 10.1056/NEJMoa2016638. Epub 2020 Jun 3.

    PMID: 32492293BACKGROUND

  • Lother SA, Abassi M, Agostinis A, Bangdiwala AS, Cheng MP, Drobot G, Engen N, Hullsiek KH, Kelly LE, Lee TC, Lofgren SM, MacKenzie LJ, Marten N, McDonald EG, Okafor EC, Pastick KA, Pullen MF, Rajasingham R, Schwartz I, Skipper CP, Turgeon AF, Zarychanski R, Boulware DR. Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial. Can J Anaesth. 2020 Sep;67(9):1201-1211. doi: 10.1007/s12630-020-01684-7. Epub 2020 May 7.

    PMID: 32383125BACKGROUND

MeSH Terms

Conditions

Coronavirus InfectionsSevere Acute Respiratory SyndromeCOVID-19

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsRespiratory Tract DiseasesPneumonia, ViralPneumoniaLung Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Todd C Lee, MD MPH FIDSA

    Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 5, 2020

First Posted

June 9, 2020

Study Start

March 25, 2020

Primary Completion

August 17, 2020

Study Completion

August 17, 2020

Last Updated

October 15, 2024

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

De-identified dataset will be included with publication.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
At time of publication
Access Criteria
To be publicly provided

Locations

CA(7)US(1)