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Effectiveness of Hydroxychloroquine in Covid-19 Patients (Covid)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04328272
Recruitment Status : Not yet recruiting
First Posted : March 31, 2020
Last Update Posted : April 2, 2020
Sponsor:
Collaborator:
Ayub Medical College, Abbottabad
Information provided by (Responsible Party):
Prof. Dr. Umar Farooq, Ayub Medical College, Abbottabad

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.

Condition or disease Intervention/treatment Phase
COVID19 Drug: Hydroxychloroquine 200 Mg Oral Tablet Drug: Azithromycin 500Mg Oral Tablet Dietary Supplement: Glucose tablets Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: three parallel groups randomly asserted for intervention
Masking: Single (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.

Primary Purpose: Treatment
Official Title: Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
Estimated Study Start Date : March 28, 2020
Estimated Primary Completion Date : May 28, 2020
Estimated Study Completion Date : June 28, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Plaquenil

Drug: Azithromycin 500Mg Oral Tablet
Azithromycin administered orally with water
Other Name: Zetro

Placebo Comparator: Suger Tablets
Placebo (sugar tablet) twice daily for 7 days
Dietary Supplement: Glucose tablets
administered orally with water
Other Name: Canderel




Primary Outcome Measures :
  1. National Early Warning Score equal to zero [ Time Frame: 3-5 Days ]
    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 :
  1. C-reactive proteins [ Time Frame: 3-5 Days ]
    below 3.0 miligram/Liter of blood sample

  2. Lymphocyte Count [ Time Frame: 3-5days ]
    1000 -4800 lymphocytes in 1 microliter of blood

  3. d-dimers [ Time Frame: 3-5days ]
    less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04328272


Contacts
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Contact: Umar Farooq, PhD 00923219111681 dean@ayubmed.edu.pk
Contact: Muhammad J Khan, MBBS 00923444566444 junaidkhan@ayubmed.edu.pk

Locations
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Pakistan
Ayub Teaching Institution
Abbottābād, K.p.k, Pakistan, 00532
Contact: Umer Farooq, PhD    00929929311100    dean@ayubmed.edu.pk   
Sponsors and Collaborators
Prof. Dr. Umar Farooq
Ayub Medical College, Abbottabad
Investigators
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Principal Investigator: Umar Farooq, PhD Khyber Medical University Peshawer
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Responsible Party: Prof. Dr. Umar Farooq, Dean & Chief Executive Officer, Ayub Medical College, Abbottabad
ClinicalTrials.gov Identifier: NCT04328272    
Other Study ID Numbers: Ath/ct101/22/3
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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

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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
Keywords provided by Prof. Dr. Umar Farooq, Ayub Medical College, Abbottabad:
covid 19
treatment
Additional relevant MeSH terms:
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Azithromycin
Hydroxychloroquine
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents