The Vietnam Chloroquine Treatment on COVID-19

NCT04328493 | Completed Phase 2 DMC

• 1 other identifier: COVID
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 5

Brief Summary

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent COVID-19 or therapeutic agent to treat COVID-19. This clinical trial is designed to evaluate potential therapeutics for the treatment of hospitalized COVID-19. We hypothesis that chloroquine slows viral replication in patients with COVID-19, attenuating the infection, and resulting in more rapid declines in viral load in throat swabs. This viral attenuation should be associated with improved patient outcomes. Given the enormous experience of its use in malaria chemoprophylaxis, excellent safety and tolerability profile, and its very low cost, if proved effective then chloroquine would be a readily deployable and affordable treatment for patients with COVID-19. The study is funded and leaded by The Ministry of Health, Vietnam.

Conditions

SARS-CoV-2 Infection; COVID-19

Keywords

SARS-CoV-2; COVID-19; chloroquine

Outcome Measures

Primary Outcomes (1)

• Viral clearance time

  Viral presence will be determined using RT-PCR to detect SARS-CoV-19 RNA. Throat/nose swabs for viral RNA will be taken daily while in hospital until there have at least 2 consecutive negative results . Virus will be defined as cleared when the patient has had ≥2 consecutive negative PCR tests. The time to viral clearance will be defined as the time following randomization to the first of the negative throat/nose swabs.

  Up to 56 days post randomization

Secondary Outcomes (8)

• Length of hospital stay

  Up to 56 days post randomization

• Ventilator free days

  first 28 days

• Oxygen free days

  first 28 days

• Time to death

  first 7, 10, 14, 28 and 56 days since randomization

• Adverse events

  Over the first 28 days (due to the prolonged half-life of Chloroquine)

Study Arms (2)

Control arm

NO INTERVENTION

Patients randomized to the control arm will receive a standard of care therapy (a supportive care/treatment according to VN MoH's guideline).

Intervention arm

EXPERIMENTAL

In addition to standard of care therapy, patients randomized to the intervention arm receive chloroquine phosphate as below. For adult ≥ 53kg: 1000mg (4 tablets) at initial dose (T=0), followed by 500mg (2 tablets) at 6 hours later (T=6), and 500mg (2 tablets) once daily for 9 days. For adult from 45 - 52kg: 875mg (3.5 tablets) at T=0, followed by 500mg (2 tablets) at T=6 and 500mg (2 tablets) once daily thereafter. For adult weighted 38 -\<45 kg: 750mg (3 tablets) at T=0, followed by 375mg (1.5 tablets) at T = 6 and 375mg (1.5 tablets) once daily thereafter. For adult weighted \<38 kg: 625mg (2.5 tablets) at T=0, followed by 375mg (1.5 tablets) at T=6 and 375mg (1.5 tablets) once daily thereafter. The total duration of treatment with chloroquine will be 10 days.

Drug: Chloroquine phosphate

Interventions

Chloroquine phosphate DRUG

Each chloroquine tablet contains 250mg chloroquine phosphate (or 150mg chloroquine base). Chloroquine treatment for patient is weight-based dosing. Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube. The total duration of treatment with Chloroquine will be 10 days

Also known as: Chloroquine

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

1. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen \< 48 hours prior to randomization, and requiring hospital admission in the opinion of the attending physician. 2. Provides written informed consent prior to initiation of any study procedures (or legally authorized representative). 3. Understands and agrees to comply with planned study procedures. 4. Agrees to the collection of OP swabs and venous blood per protocol. 5. Male or female adult ≥18 years of age at time of enrollment.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Oxford University Clinical Research Unit, Vietnam: lead
• Ministry of Health, Vietnam: collaborator
• Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam: collaborator
• Cu Chi COVID Hospital, Vietnam: collaborator
• Can Gio COVID Hospital, Vietnam: collaborator
• Cho Ray Hospital: collaborator
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator
• Department of Health, Ho Chi Minh city: collaborator

Study Sites (5)

National Hospital for Tropical Diseases

Hanoi, Vietnam

Location

Can Gio COVID Hospital

Ho Chi Minh City, Vietnam

Location

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Location

Cu Chi COVID Hospital

Ho Chi Minh City, Vietnam

Location

Hospital for Tropical Diseases

Ho Chi Minh City, Vietnam

Location

Related Publications (19)

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  PMID: 33110944 DERIVED

Related Links

• in press
• World Health Organization Model List of Essential Medicines
• COVID-19 Coronavirus Pandemic updates

MeSH Terms

Conditions

COVID-19

Interventions

chloroquine diphosphate; 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

• Guy Thwaites, PhD. MD

  University of Oxford, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The main trial is an open label, randomised, controlled trial that will be conducted in in-patients in Ho Chi Minh City. Viet Nam. Randomization will be 1:1, stratified by study site and severity of illness, to either with or without chloroquine for 10 days. All patients will also receive a supportive care/treatment according to VN MoH's guideline for COVID-19

Study Record Dates

• First Submitted: March 27, 2020
• First Posted: March 31, 2020
• Study Start: April 7, 2020
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (5)