PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds

NCT04351191 | Terminated Phase 4 DMC

• 1 other identifier: NBC-COVID1902
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 4

Brief Summary

To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.

Conditions

Sars-CoV2; Symptomatic Condition; Covid-19

Outcome Measures

Primary Outcomes (1)

• RT-PCR result

  Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7

  6th and 7th day

Secondary Outcomes (2)

• Progression of symptoms

  7 days

• Mortality

  30 days

Study Arms (4)

HCQ Regular dose

ACTIVE COMPARATOR

Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care

Drug: Hydroxychloroquine Sulfate Regular dose

HCQ Loading dose

EXPERIMENTAL

Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care

Drug: Hydroxychloroquine Sulfate Loading Dose

CQ regular dose

ACTIVE COMPARATOR

Cholorquine 500 mg BID for 5 days plus standard of care

Drug: Chloroquine

Placebo

PLACEBO COMPARATOR

Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)

Drug: Placebo

Interventions

Hydroxychloroquine Sulfate Regular dose DRUG

Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

HCQ Regular dose

Hydroxychloroquine Sulfate Loading Dose DRUG

Hydroxychloroquine administered as a loading dose only

HCQ Loading dose

Chloroquine DRUG

Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2

CQ regular dose

Placebo DRUG

Standard of Care plus placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate \>22 per minute).
• Nasopharyngeal RT-PCR positive SARS-CoV-2
• Age 20-50 years
• BMI 18-28 kg/m2
• Informed consent

You may not qualify if:

• O2 saturation by pulse-oximeter below 93%
• Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
• Arrhythmias and/or history of arrythmia
• Psoriasis and/or history of psoriasis
• Neuropathy or myopathy and/or history of these
• Hypoglycemia and/or history of hypoglycemia
• Pre-existing hepatic disease
• Pre-existing renal disease
• Use of antacids within 1 week
• Use of antiobiotics within 1 week
• Pregnancy
• RT-PCR performed \>7 days prior to enrollment

Sponsors & Collaborators

• Government of Punjab, Specialized Healthcare and Medical Education Department: lead
• Mayo Hospital Lahore: collaborator
• Services Hospital, Lahore: collaborator
• Pakistan Kidney and Liver Institute: collaborator

Study Sites (4)

Expo Covid Isolation Center / Mayo Hospital Field Hospital

Lahore, Punjab Province, Pakistan

Location

Mayo Hospital / King Edward Medical University

Lahore, Punjab Province, Pakistan

Location

Pakistan Kidney and Liver Institute

Lahore, Punjab Province, Pakistan

Location

Services Hospital

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

Chloroquine

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)

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

Study Officials

• Ammar Sarwar, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School

Model Details: Prospective double blind randomized superiority clinical trial.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: April 15, 2020
• Primary Completion: August 23, 2020
• Study Completion: August 30, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (4)