SARS-CoV-2NCT04370015
Hydroxychloroquine Chemoprophylaxis for COVID-19 Infection in High-risk Healthcare Workers.
A study testing Hydroxychloroquine in people with SARS-CoV-2 and Healthcare Workers, run by Services Institute of Medical Sciences, Pakistan.
Trial summary
Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, Healthcare Workers
- What is being tested?
- Hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2020to 15 Oct 2020
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent.
- Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below):
- Healthcare workers in Corona triage areas.
- Healthcare workers in Corona Isolation Units.
- Healthcare workers in Corona ICUs.
- Healthcare workers in general medical wards.
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- Healthcare workers in general surgical wards.
- Healthcare workers in other units not directly dealing with suspected Corona patients e.g. Endocrinology department
- Afebrile with no constitutional symptoms.
- No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks.
- Negative PCR at visit 0.
- Willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- Willing to not take any other medicines especially fluoroquinolones and macrolides for the duration of study.
- Signed informed consent, demonstrating that the subject understands the interventions required for the study and the purpose of the study.
Who cannot join
- Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days.
- Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study.
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria.
- Taking any of the following medication:
- Anti-arrythmic agents including digoxin.
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- GI drugs including antacids, proton-pump inhibitors, cimetidine.
- Anti-cancer treatment including methotrexate, cyclosporin.
- Anti-diabetic agents including insulin.
- Corticosteroids.
- Drugs causing QT interval prolongation especially antidepressants, anti-epileptics and macrolides.
- Drugs affecting electrolyte balance including diuretics, laxatives.
- Drug allergies: 4-Aminoquinolines.
- Pre-existing retinopathy/maculopathy of the eye.
- Known chronic liver disease or cirrhosis, including hepatitis B and/or untreated hepatitis.
- Previous history of severe hypoglycaemia.
- Known case of renal disease.
- Untreated or uncontrolled active bacterial, fungal infection.
- Known or suspected active drug or alcohol abuse.
- Women who are pregnant or breastfeeding.
- Known hypersensitivity to any component of the study drug.
- A known history of prolonged QT syndrome or history of additional risk factors for arrythmias (e.g., heart failure, family history of Long QT Syndrome).
- Known H/O respiratory disorders e.g. asthma, chronic obstructive pulmonary disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial
Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.
Read the detailed description
An interventional randomised control trial that will include 374 participants who will be healthcare workers at variable risks of exposure to SARS-CoV-2 while managing patients both suspected and confirmed with COVID-19 infection.Each participant will undergo detailed clinical evaluation to confirm eligibility, complete blood count, retinal imaging and ECG rhythm lead at baseline. A nasopharyngeal swab for reverse-transcriptase-polymerase chain reaction (RT-PCR) will also be taken. The enrolled participants will be randomised to two treatment arms with the experimental arm receiving Tab.Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400mg weekly for 11 weeks. The placebo comparator arm will receive 2 tablets twice daily on day 1 followed by 2 tablets weekly for 11 weeks. The participants will be followed up via phone call weekly to ensure drug compliance, occurrence of drug-related side effects or respiratory symptoms. The final visit 4 will mark the end of study at 12 weeks from randomisation when a repeat nasopharyngeal swab for SARS-CoV-2 RT-PCR will be taken.The primary outcome measures will be prevention of SARS-CoV-2 infection as determined by a negative RT-PCR in the experimental arm at the end of 12 weeks and HCQ safety as determined by occurrence of adverse events.
- Conditions
- SARS-CoV-2, Healthcare Workers
- Being tested
- Hydroxychloroquine, Placebo oral tablet
- Keywords
- SARS-CoV-2, HCQ, prophylaxis, healthcare workers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called HCQ
Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.
Placebo oral tabletDrug
- Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks. Receives: Drug: Hydroxychloroquine |
| Control group | Placebo comparator | Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks. Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period
Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
Measured: From date of randomization until study completion 12 weeks after treatment initiation
Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment
To assess the presence or absence of side effects from HCQ treatment.
Measured: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Secondary outcomes (3)
Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR
Symptomatic infection by SARS-CoV-2 defined as cough, dyspnea, fever, myalgia, arthralgia or rhinorrhea.
Measured: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Clinical disease severity in confirmed SARS-CoV-2 participants
Disease severity including i) asymptomatic. ii) Mild symptoms but ambulatory. iii) Moderate symptoms requiring hospitalisation. iv) severe symptoms requiring ICU care and oxygen. v) Severe symptoms requiring assisted mechanical ventilation. vi) Death.
Measured: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Incidence of any acute respiratory infection
Symptomatic non-COVID viral infection (any other acute respiratory illness with fever but without evidence of epidemiological risk factors such as close contact with SARS-CoV-2 positive patient or travel to or residence in high-risk area).
Measured: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 May 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion15 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 374 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Saira Burney, Services Institute of Medical Sciences, Pakistan
- Investigators
- Saira Burney, FRCP (Edin), Principal investigator, SIMS SIUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370015
- Sponsor's protocol ID
- 16082019
- Status last verified
- May 2020
- First submitted
- 27 Apr 2020
- Last updated
- 6 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04370015
- Acronym / sponsor ID
- 16082019
- Conditions
- SARS-CoV-2, Healthcare Workers
- Keywords
- SARS-CoV-2, HCQ, prophylaxis, healthcare workers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 374 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 15 Oct 2020 (estimated)
- First posted
- 30 Apr 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.
Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.
Detailed description
An interventional randomised control trial that will include 374 participants who will be healthcare workers at variable risks of exposure to SARS-CoV-2 while managing patients both suspected and confirmed with COVID-19 infection.Each participant will undergo detailed clinical evaluation to confirm eligibility, complete blood count, retinal imaging and ECG rhythm lead at baseline. A nasopharyngeal swab for reverse-transcriptase-polymerase chain reaction (RT-PCR) will also be taken. The enrolled participants will be randomised to two treatment arms with the experimental arm receiving Tab.Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400mg weekly for 11 weeks. The placebo comparator arm will receive 2 tablets twice daily on day 1 followed by 2 tablets weekly for 11 weeks. The participants will be followed up via phone call weekly to ensure drug compliance, occurrence of drug-related side effects or respiratory symptoms. The final visit 4 will mark the end of study at 12 weeks from randomisation when a repeat nasopharyngeal swab for SARS-CoV-2 RT-PCR will be taken.The primary outcome measures will be prevention of SARS-CoV-2 infection as determined by a negative RT-PCR in the experimental arm at the end of 12 weeks and HCQ safety as determined by occurrence of adverse events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: HydroxychloroquineHealth care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks. |
| Control group | Placebo comparator | Drug: Placebo oral tabletHealth care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Adult healthcare workers all genders ≥ 18 to ≤ 60 years of age upon study consent.
- Healthcare workers (doctors and nurses) at Services hospital, Lahore considered work at high-risk of SARS-CoV-2 exposure (defined below):
- Afebrile with no constitutional symptoms.
- No household contact with confirmed active SARS-CoV-2 infection in the last 3 weeks.
- Negative PCR at visit 0.
Key exclusion criteria (23 listed)
- Participation in other investigational clinical trials for the treatment or prevention of SARS-CoV-2 infection within 30days.
- Subjects unwilling to practice at least one highly effective method of birth control for the duration of the study.
- Having a prior history of blood disorders such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia or prior history of glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
- Having H/O skin disorders e.g. dermatitis, psoriasis or porphyria.
- Taking any of the following medication:
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 |
|---|---|---|
| HydroxychloroquineAlso: HCQHealth care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks. | Drug | Treatment group |
| Placebo oral tablet• Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks. | Drug | Control group |
Primary outcome
Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period
Time frame: From date of randomization until study completion 12 weeks after treatment initiation
Negative RT-PCR for SARS-CoV-2 both at baseline and at end of 12 weeks in experimental arm
Safety as determined by presence or absence of any adverse event related with hydroxychloroquine treatment
Time frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
To assess the presence or absence of side effects from HCQ treatment.
3 secondary outcomes
Confirmed SARS-CoV-2 infection based on symptoms and confirmed by RT-PCR
Time frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Clinical disease severity in confirmed SARS-CoV-2 participants
Time frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Incidence of any acute respiratory infection
Time frame: From date of randomization until the appearance of symptoms or study completion 12 weeks after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Individual participant dataSharing planned: No
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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.
Saira Burney, FRCP (Edin) principal investigator
SIMS SIUT
Questions about this trial
What is this clinical trial studying?
A study testing Hydroxychloroquine in people with SARS-CoV-2 and Healthcare Workers, run by Services Institute of Medical Sciences, 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 14 inclusion and 23 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 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Saira Burney, FRCP (Edin) (923014226617, dr_syra@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of SARS-CoV-2 as determined by negative RT-PCR at the end of 12 week study period (time frame: From date of randomization until study completion 12 weeks after treatment initiation). The study lists 2 primary outcomes in all. 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 6 May 2020.