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Effectiveness of Hydroxychloroquine in Covid-19 Patients (Covid)

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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

Tracking Information
First Submitted Date  ICMJE March 25, 2020
First Posted Date  ICMJE March 31, 2020
Last Update Posted Date April 2, 2020
Estimated Study Start Date  ICMJE March 28, 2020
Estimated Primary Completion Date May 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
  • C-reactive proteins [ Time Frame: 3-5 Days ]
    below 3.0 miligram/Liter of blood sample
  • Lymphocyte Count [ Time Frame: 3-5days ]
    1000 -4800 lymphocytes in 1 microliter of blood
  • d-dimers [ Time Frame: 3-5days ]
    less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Hydroxychloroquine in Covid-19 Patients
Official Title  ICMJE Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE COVID19
Intervention  ICMJE
  • 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
  • Dietary Supplement: Glucose tablets
    administered orally with water
    Other Name: Canderel
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Hydroxychloroquine 200 Mg Oral Tablet
  • 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.
    Interventions:
    • Drug: Hydroxychloroquine 200 Mg Oral Tablet
    • Drug: Azithromycin 500Mg Oral Tablet
  • Placebo Comparator: Suger Tablets
    Placebo (sugar tablet) twice daily for 7 days
    Intervention: Dietary Supplement: Glucose tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 27, 2020)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 28, 2020
Estimated Primary Completion Date May 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Umar Farooq, PhD 00923219111681 dean@ayubmed.edu.pk
Contact: Muhammad J Khan, MBBS 00923444566444 junaidkhan@ayubmed.edu.pk
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04328272
Other Study ID Numbers  ICMJE Ath/ct101/22/3
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Responsible Party Prof. Dr. Umar Farooq, Ayub Medical College, Abbottabad
Study Sponsor  ICMJE Prof. Dr. Umar Farooq
Collaborators  ICMJE Ayub Medical College, Abbottabad
Investigators  ICMJE
Principal Investigator: Umar Farooq, PhD Khyber Medical University Peshawer
PRS Account Ayub Medical College, Abbottabad
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP