Effectiveness of Hydroxychloroquine in Covid-19 Patients (Covid)

Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study

To find the effectiveness of hydroxychloroquine alone and adjuvant with azithromycin in mild to severe Covide-19 pneumonia patients admitted to Coronavirus cell/ward of Ayub Teaching hospital, Abbottabad Pakistan. A single centered, single-blind randomized control trial study.

Study Overview

• Status: Unknown
• Conditions: COVID19
• Intervention / Treatment: Drug: Hydroxychloroquine 200 Mg Oral Tablet; Drug: Azithromycin 500Mg Oral Tablet; Dietary supplement: Glucose tablets

Detailed Description

Coronavirus (SARS-nCoV-2) is a member family coronaviridae, order Nidovirales. It is single-stranded, positive sense enveloped RNA discovered in early 1960s. Coronavirus pandemic put a lot of lives at stake. By 19 March 2020, a total of 219238 confirmed cases with 8967 being dead and 85742 recovered cases have been reported. Worldwide, in 9 days, the confirmed death cases have been doubled. The average death rate of Covid-19 per day is approximately 88 patients as of the given date. Unlike, SARS-CoV and MERS-CoV, the disease progression and mortality rate of Covid-19 is startling. The pre-pathogenic course of novel Covid-19 is yet to be determined, so the risk factors, clinical picture and medical intervention too. Only supportive therapy is being practised. Yet many trials of antimalarial drug, chloroquine and quinolone is currently taking place worldwide. According to Cortegiani A, 23 ongoing trials from China have been registered. Clinical experience from recent Wuhan epidemic came up with promising results of chloroquine and hydroxychloroquine in Covid-19 positive patients. Some in-vitro studies suggest that these immunomodulant drugs can interfere with SARS-nCov-2 replication. These are federal drug authority approved medicine for malaria. Yet their effectiveness and safety in treating Covid-19 pneumonia is a question mark.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Umar Farooq, PhD; Phone Number: 00923219111681; Email: dean@ayubmed.edu.pk
• Study Contact Backup: Name: Muhammad J Khan, MBBS; Phone Number: 00923444566444; Email: junaidkhan@ayubmed.edu.pk

Study Locations

• Pakistan
  • K.p.k
    • Abbottābād, K.p.k, Pakistan, 00532
      • Ayub Teaching Institution
      • Contact: Umer Farooq, PhD; Phone Number: 00929929311100; Email: dean@ayubmed.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
• Mild to severe clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6)

Exclusion Criteria:

• Covid-19 critically ill patients (NEWS-2 score <7),
• Unable to take oral medication,
• Immunocompromised,
• Creatinine clearance (CCL) < 30 ml/min,
• Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN),
• d-dimer > 2microgram per liter, or
• Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites, asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
• BMI less than 18
• Smoking history (one pack per day) for past six months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxychloroquine; tablet hydroxychloroquine (HCQ). Day-1 (initial) 1st dose, 3 tablets (200 mg per tablet), 2nd dose after 6 hours, 3 tablets (200 mg per tablet) per oral. From day 2 to 7 (maintenance dose), 2 tablets twice a day.	Drug: Hydroxychloroquine 200 Mg Oral Tablet; Hydroxychloroquine administered orally with water; Other Names: Plaquenil
Active Comparator: Azithromycin; Tablet azithromycin (AZC) 500 mg orally as a single dose on day 1, followed by 250 mg orally once a day on days 2 to 7.	Drug: Hydroxychloroquine 200 Mg Oral Tablet; Hydroxychloroquine administered orally with water; Other Names: Plaquenil; Drug: Azithromycin 500Mg Oral Tablet; Azithromycin administered orally with water; Other Names: Zetro
Placebo Comparator: Suger Tablets; Placebo (sugar tablet) twice daily for 7 days	Dietary supplement: Glucose tablets; administered orally with water; Other Names: Canderel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Early Warning Score equal to zero	National Early Warning Score equal to zero is when patients recovered clinically. Respiration 14-20breaths/minute, oxygen saturation percent greater than 96, (without breathing aid), systolic blood pressure 111-180 mmhg, pulse 60-90 beats.minute, alert consciousness and 35.1-38 degree Celsius body temperature.	3-5 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
C-reactive proteins	below 3.0 miligram/Liter of blood sample	3-5 Days
Lymphocyte Count	1000 -4800 lymphocytes in 1 microliter of blood	3-5days
d-dimers	less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample	3-5days

Collaborators and Investigators

• Sponsor: Prof. Dr. Umar Farooq
• Collaborators: Ayub Medical College, Abbottabad
• Investigators: Principal Investigator: Umar Farooq, PhD, Khyber Medical University Peshawer

Study record dates

Study Major Dates

• Study Start (Anticipated): March 28, 2020
• Primary Completion (Anticipated): May 28, 2020
• Study Completion (Anticipated): June 28, 2020

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2020
• Last Update Submitted That Met QC Criteria: March 31, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: treatment; covid 19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Anti-Bacterial Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Azithromycin; Hydroxychloroquine
• Other Study ID Numbers: Ath/ct101/22/3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: as each individual will have his/her own coded file. the required data from each will be extracted and will be made available in soft copies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No