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Effectiveness of Hydroxychloroquine in Covid-19 Patients (Covid)

Primary Purpose

COVID19

Status
Unknown status
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Hydroxychloroquine 200 Mg Oral Tablet
Azithromycin 500Mg Oral Tablet
Glucose tablets
Sponsored by
Prof. Dr. Umar Farooq
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID19 focused on measuring covid 19, treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ayub Teaching Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Hydroxychloroquine

Azithromycin

Suger Tablets

Arm Description

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.

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.

Placebo (sugar tablet) twice daily for 7 days

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

C-reactive proteins
below 3.0 miligram/Liter of blood sample
Lymphocyte Count
1000 -4800 lymphocytes in 1 microliter of blood
d-dimers
less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample

Full Information

First Posted
March 25, 2020
Last Updated
March 31, 2020
Sponsor
Prof. Dr. Umar Farooq
Collaborators
Ayub Medical College, Abbottabad
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1. Study Identification

Unique Protocol Identification Number
NCT04328272
Brief Title
Effectiveness of Hydroxychloroquine in Covid-19 Patients
Acronym
Covid
Official Title
Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 28, 2020 (Anticipated)
Primary Completion Date
May 28, 2020 (Anticipated)
Study Completion Date
June 28, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dr. Umar Farooq
Collaborators
Ayub Medical College, Abbottabad

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID19
Keywords
covid 19, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
three parallel groups randomly asserted for intervention
Masking
Participant
Masking Description
Single blinded: As, the disease is novel and putting the lives at risk is unethical. therefore, It is important for investigator to know the group and carry close regular monitoring of participants so that proper further intervention can be made when required.
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydroxychloroquine
Arm Type
Experimental
Arm Description
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.
Arm Title
Azithromycin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Suger Tablets
Arm Type
Placebo Comparator
Arm Description
Placebo (sugar tablet) twice daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine 200 Mg Oral Tablet
Other Intervention Name(s)
Plaquenil
Intervention Description
Hydroxychloroquine administered orally with water
Intervention Type
Drug
Intervention Name(s)
Azithromycin 500Mg Oral Tablet
Other Intervention Name(s)
Zetro
Intervention Description
Azithromycin administered orally with water
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose tablets
Other Intervention Name(s)
Canderel
Intervention Description
administered orally with water
Primary Outcome Measure Information:
Title
National Early Warning Score equal to zero
Description
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.
Time Frame
3-5 Days
Secondary Outcome Measure Information:
Title
C-reactive proteins
Description
below 3.0 miligram/Liter of blood sample
Time Frame
3-5 Days
Title
Lymphocyte Count
Description
1000 -4800 lymphocytes in 1 microliter of blood
Time Frame
3-5days
Title
d-dimers
Description
less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Time Frame
3-5days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umar Farooq, PhD
Phone
00923219111681
Email
dean@ayubmed.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad J Khan, MBBS
Phone
00923444566444
Email
junaidkhan@ayubmed.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umar Farooq, PhD
Organizational Affiliation
Khyber Medical University Peshawer
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ayub Teaching Institution
City
Abbottābād
State/Province
K.p.k
ZIP/Postal Code
00532
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umer Farooq, PhD
Phone
00929929311100
Email
dean@ayubmed.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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

Learn more about this trial

Effectiveness of Hydroxychloroquine in Covid-19 Patients

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