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Completed

NCT Number: NCT04491994

Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression

Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate Phase: Phase III

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Disease Progression Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Progression RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pak Emirates Military Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

This study explores efficacy of HCQ (400mg BD on D0 and 200mg BD D1-D5) in reducing progression of Mild Covid-19 patients and decreasing viral load.

Participants of study will be randomized 2:1 to receive either Active drug or standard of care (SOC) treatment respectively. We aim to demonstrate reduced COVID-19 progression and early viral clearance in individuals on HCQ therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mild Corona virus disease (COVID-19)
  • PCR confirmed infection
  • Hospital admitted patients

Exclusion criteria

  • Moderate, severe and critical COVID-19
  • day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest
  • comorbidity with life expectancy less than 6 months
  • Contraindications to HCQ therapy

Treatment and study plan

HCQ

Drug

Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days

Other names: HCQ + Standard of Care (SOC)

Primary outcomes

  1. Number of Participants With Progression

    Time frame: 5 days

    After start of treatment, development of fever > 101 F for > 72 hours, shortness of breath by minimal exertion (10-Step walk test), derangement of basic lab parameters (ALC < 1000 or raised CRP) or appearance of infiltrates on CXR during course of treatment was labeled as progression irrespective of PCR status

Secondary outcomes

  1. Viral Clearance

    Time frame: 14 days

    PCR negativity on day 7 and 14 after admission

Sponsors and collaborators

Lead sponsor

UNICEF

Other

Collaborators

  • Pak Emirates Military Hospital

Registry information

Official study title

Clearing the Fog: Is HCQ Effective in Reducing COVID-19 progression-a Randomized Controlled Trial

Acronym: COVID-19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 30, 2020
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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