NCT04328272

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Mar 2020

Shorter than P25 for phase_3 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

March 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

2 months

First QC Date

March 25, 2020

Last Update Submit

March 31, 2020

Conditions

COVID19

Keywords

covid 19treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • C-reactive proteins

    3-5 Days

  • Lymphocyte Count

    3-5days

  • d-dimers

    3-5days

Study Arms (3)

Hydroxychloroquine

EXPERIMENTAL

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

Azithromycin

ACTIVE COMPARATOR

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 TabletDrug: Azithromycin 500Mg Oral Tablet

Suger Tablets

PLACEBO COMPARATOR

Placebo (sugar tablet) twice daily for 7 days

Dietary Supplement: Glucose tablets

Interventions

Hydroxychloroquine 200 Mg Oral TabletDRUG

Hydroxychloroquine administered orally with water

Also known as: Plaquenil
AzithromycinHydroxychloroquine
Azithromycin 500Mg Oral TabletDRUG

Azithromycin administered orally with water

Also known as: Zetro
Azithromycin
Glucose tabletsDIETARY_SUPPLEMENT

administered orally with water

Also known as: Canderel
Suger Tablets

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayub Teaching Institution

Abbottābād, K.p.k, 00532, Pakistan

Location

MeSH Terms

Conditions

COVID-19

Interventions

HydroxychloroquineAzithromycinGlucoseAspartame

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsHexosesMonosaccharidesSugarsCarbohydratesDipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Umar Farooq, PhD

    Khyber Medical University Peshawer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Umar Farooq, PhD

CONTACT

00923219111681dean@ayubmed.edu.pk

Muhammad J Khan, MBBS

CONTACT

00923444566444junaidkhan@ayubmed.edu.pk

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: three parallel groups randomly asserted for intervention
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean & Chief Executive Officer

Study Record Dates

First Submitted

March 25, 2020

First Posted

March 31, 2020

Study Start

March 28, 2020

Primary Completion

May 28, 2020

Study Completion

June 28, 2020

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

PA(1)