Effectiveness of Hydroxychloroquine in Covid-19 Patients

COVID19 Clinical Trial

— Covid  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04328272
• Other study ID #: Ath/ct101/22/3
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 28, 2020
• Est. completion date: June 28, 2020

Study information

• Verified date: March 2020
• Source: Ayub Medical College, Abbottabad
• Contact: Umar Farooq, PhD
• Phone: 00923219111681
• Email: dean[@]ayubmed.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: June 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID19

Intervention

Drug:
• Hydroxychloroquine 200 Mg Oral Tablet
Hydroxychloroquine administered orally with water
• Azithromycin 500Mg Oral Tablet
Azithromycin administered orally with water

Dietary Supplement:
• Glucose tablets
administered orally with water

Locations

Country	Name	City	State
Pakistan	Ayub Teaching Institution	Abbottabad	K.p.k

Sponsors (2)

Lead Sponsor	Collaborator
Prof. Dr. Umar Farooq	Ayub Medical College, Abbottabad

Country where clinical trial is conducted

Pakistan, 

Outcome

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