Effectiveness of Hydroxychloroquine in Covid-19 Patients

NCT04328272 — Phase 3, Unknown, 75 participants, Prof. Dr. Umar Farooq

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

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

RegistryNCT04328272, acronym Covid
StatusUnknown
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment75 (Estimated)
SponsorProf. Dr. Umar Farooq (Other); collaborators: Ayub Medical College, Abbottabad
ConditionsCOVID19
InterventionsHydroxychloroquine 200 Mg Oral Tablet, Azithromycin 500Mg Oral Tablet, Glucose tablets (Drug, dietary supplement)
Datesstart 2020-03-28 (estimated), primary completion 2020-05-28 (estimated), completion 2020-06-28 (estimated), first posted 2020-03-31, last updated 2020-04-02
Locations1 site in Pakistan

Related Papers Related Patents Related Grants Related Experts
All trials for COVID19 All trials of Hydroxychloroquine 200 Mg Oral Tablet All trials of Azithromycin 500Mg Oral Tablet

-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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
HydroxychloroquineExperimentalDrug: Hydroxychloroquine 200 Mg Oral Tablettablet 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.
AzithromycinActive comparatorDrug: Hydroxychloroquine 200 Mg Oral Tablet; Drug: Azithromycin 500Mg Oral TabletTablet 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.
Suger TabletsPlacebo comparatorDietary Supplement: Glucose tabletsPlacebo (sugar tablet) twice daily for 7 days
  • Hydroxychloroquine 200 Mg Oral Tablet (Drug), also known as Plaquenil: Hydroxychloroquine administered orally with water
  • Azithromycin 500Mg Oral Tablet (Drug), also known as Zetro: Azithromycin administered orally with water
  • Glucose tablets (Dietary supplement), also known as Canderel: administered orally with water

+Outcome measures

Primary outcomes

  • National Early Warning Score equal to zero [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 outcomes

  • C-reactive proteins [3-5 Days]: below 3.0 miligram/Liter of blood sample
  • Lymphocyte Count [3-5days]: 1000 -4800 lymphocytes in 1 microliter of blood
  • d-dimers [3-5days]: less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample

+Eligibility

Sex: All, ages: 18 Years to 50 Years

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

+Locations (1)

FacilityCityCountryStatus
Ayub Teaching InstitutionAbbottābād, K.p.kPakistan

+Investigators