COVID19Phase 3CovidNCT04328272
Effectiveness of Hydroxychloroquine in Covid-19 Patients
A Phase 3 study testing Hydroxychloroquine 200 Mg Oral Tablet, Azithromycin 500Mg Oral Tablet and Glucose tablets in people with COVID19, run by Prof. Dr. Umar Farooq at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- COVID19
- What is being tested?
- Hydroxychloroquine 200 Mg Oral Tablet, Azithromycin 500Mg Oral Tablet and Glucose tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Mar 2020to 28 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ayub Teaching Institution
Abbottābād, K.p.k, 00532
Umer Farooq, PhD, 00929929311100, dean@ayubmed.edu.pk
About this study
Official title: Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
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.
Read the 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.
- Conditions
- COVID19
- Being tested
- Hydroxychloroquine 200 Mg Oral Tablet, Azithromycin 500Mg Oral Tablet, Glucose tablets
- Keywords
- covid 19, treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine 200 Mg Oral TabletDrug
Also called Plaquenil
Hydroxychloroquine administered orally with water
Azithromycin 500Mg Oral TabletDrug
Also called Zetro
Azithromycin administered orally with water
Glucose tabletsDietary supplement
Also called Canderel
administered orally with water
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydroxychloroquine 200 Mg Oral Tablet; Drug: Azithromycin 500Mg Oral Tablet |
| Suger Tablets | Placebo comparator | Placebo (sugar tablet) twice daily for 7 days Receives: Dietary Supplement: Glucose tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-5 Days
Secondary outcomes (3)
C-reactive proteins
below 3.0 miligram/Liter of blood sample
Measured: 3-5 Days
Lymphocyte Count
1000 -4800 lymphocytes in 1 microliter of blood
Measured: 3-5days
d-dimers
less than 250 ng/mL, or less than 0.4 mcg/mL of blood sample
Measured: 3-5days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start28 Mar 2020 (estimated)
- Primary completion28 May 2020 (estimated)
- Study completion28 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three parallel groups randomly asserted for intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Umar Farooq
- Sponsor type
- University, hospital or other
- Collaborators
- Ayub Medical College, Abbottabad
- Responsible party
- Sponsor-investigator, Prof. Dr. Umar Farooq, Ayub Medical College, Abbottabad
- Investigators
- Umar Farooq, PhD, Principal investigator, Khyber Medical University Peshawer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328272
- Sponsor's protocol ID
- Ath/ct101/22/3
- Acronym
- Covid
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 2 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study
- ClinicalTrials.gov ID
- NCT04328272
- Acronym / sponsor ID
- Covid / Ath/ct101/22/3
- Conditions
- COVID19
- Keywords
- covid 19, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Prof. Dr. Umar FarooqUniversity, hospital or other
- Collaborators
- Ayub Medical College, Abbottabad
- Study start
- 28 Mar 2020 (estimated)
- Primary completion
- 28 May 2020 (estimated)
- Study completion
- 28 Jun 2020 (estimated)
- First posted
- 31 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- three parallel groups randomly asserted for intervention
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: 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. |
| Azithromycin | Active comparator | Drug: 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 Tablets | Placebo comparator | Dietary Supplement: Glucose tabletsPlacebo (sugar tablet) twice daily for 7 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxychloroquine 200 Mg Oral TabletAlso: PlaquenilHydroxychloroquine administered orally with water | Drug | Azithromycin, Hydroxychloroquine |
| Azithromycin 500Mg Oral TabletAlso: ZetroAzithromycin administered orally with water | Drug | Azithromycin |
| Glucose tabletsAlso: Candereladministered orally with water | Dietary supplement | Suger Tablets |
Primary outcome
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.
3 secondary outcomes
C-reactive proteins
Time frame: 3-5 Days
Lymphocyte Count
Time frame: 3-5days
d-dimers
Time frame: 3-5days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Umar Farooq, PhD principal investigator
Khyber Medical University Peshawer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxychloroquine 200 Mg Oral Tablet, Azithromycin 500Mg Oral Tablet and Glucose tablets in people with COVID19, run by Prof. Dr. Umar Farooq at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umar Farooq, PhD (00923219111681, dean@ayubmed.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Early Warning Score equal to zero (time frame: 3-5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020.