Sars-CoV2Phase 4PRECISENCT04351191
PRophylaxis of Exposed COVID-19 Individuals With Mild Symptoms Using choloroquinE Compounds
A Phase 4 study testing Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine in people with Sars-CoV2 and Symptomatic Condition, run by Government of Punjab, Specialized Healthcare and Medical Education Department at 4 sites in Pakistan.
Trial summary
To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Sars-CoV2, Symptomatic Condition, Covid-19
- What is being tested?
- Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 4 sitesPakistan
- Study dates
- 15 Apr 2020to 30 Aug 2020
- Phase
- Phase 4
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- Nasopharyngeal RT-PCR positive SARS-CoV-2
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Who cannot join
- O2 saturation by pulse-oximeter below 93%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
- Hypoglycemia and/or history of hypoglycemia
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- Pre-existing hepatic disease
- Pre-existing renal disease
- Use of antacids within 1 week
- Use of antiobiotics within 1 week
- Pregnancy
- RT-PCR performed >7 days prior to enrollment
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites
Expo Covid Isolation Center / Mayo Hospital Field Hospital
Lahore, Punjab Province
Mayo Hospital / King Edward Medical University
Lahore, Punjab Province
Pakistan Kidney and Liver Institute
Lahore, Punjab Province
Services Hospital
Lahore, Punjab Province
About this study
Official title: Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.
- Conditions
- Sars-CoV2, Symptomatic Condition, Covid-19
- Being tested
- Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose, Chloroquine, Placebo
- 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 Sulfate Regular doseDrug
Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
Hydroxychloroquine Sulfate Loading DoseDrug
Hydroxychloroquine administered as a loading dose only
ChloroquineDrug
Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
PlaceboDrug
Standard of Care plus placebo
| Study group | Role | What they receive |
|---|---|---|
| HCQ Regular dose | Active comparator | Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care Receives: Drug: Hydroxychloroquine Sulfate Regular dose |
| HCQ Loading dose | Experimental | Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care Receives: Drug: Hydroxychloroquine Sulfate Loading Dose |
| CQ regular dose | Active comparator | Cholorquine 500 mg BID for 5 days plus standard of care Receives: Drug: Chloroquine |
| Placebo | Placebo comparator | Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
RT-PCR result
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
Measured: 6th and 7th day
Secondary outcomes (2)
Progression of symptoms
Time to progression to next stage of SARS-CoV-2 disease severity index
Measured: 7 days
Mortality
Death
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start15 Apr 2020
- Primary completion23 Aug 2020
- Study completion30 Aug 2020
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sars-CoV2Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective double blind randomized superiority clinical trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government of Punjab, Specialized Healthcare and Medical Education Department
- Sponsor type
- Other government
- Collaborators
- Mayo Hospital Lahore, Services Hospital, Lahore, Pakistan Kidney and Liver Institute
- Responsible party
- Principal investigator, Ammar Sarwar, Beth Israel Deaconess Medical Center
- Investigators
- Ammar Sarwar, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351191
- Sponsor's protocol ID
- NBC-COVID1902
- Acronym
- PRECISE
- Status last verified
- Mar 2021
- First submitted
- 14 Apr 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic RT-PCR Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
- ClinicalTrials.gov ID
- NCT04351191
- Acronym / sponsor ID
- PRECISE / NBC-COVID1902
- Conditions
- Sars-CoV2, Symptomatic Condition, Covid-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Government of Punjab, Specialized Healthcare and Medical Education DepartmentOther government
- Collaborators
- Mayo Hospital Lahore, Services Hospital, Lahore, Pakistan Kidney and Liver Institute
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 23 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 17 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.
To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective double blind randomized superiority clinical trial.
| Arm | Type | Receives |
|---|---|---|
| HCQ Regular dose | Active comparator | Drug: Hydroxychloroquine Sulfate Regular doseHydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care |
| HCQ Loading dose | Experimental | Drug: Hydroxychloroquine Sulfate Loading DoseHydroxychloroquine loading dose (400 mg BID) alone plus standard of care |
| CQ regular dose | Active comparator | Drug: ChloroquineCholorquine 500 mg BID for 5 days plus standard of care |
| Placebo | Placebo comparator | Drug: PlaceboStandard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine) |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- Nasopharyngeal RT-PCR positive SARS-CoV-2
- Age 20-50 years
- BMI 18-28 kg/m2
- Informed consent
Key exclusion criteria (12 listed)
- O2 saturation by pulse-oximeter below 93%
- Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- Arrhythmias and/or history of arrythmia
- Psoriasis and/or history of psoriasis
- Neuropathy or myopathy and/or history of these
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 Sulfate Regular doseHydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 | Drug | HCQ Regular dose |
| Hydroxychloroquine Sulfate Loading DoseHydroxychloroquine administered as a loading dose only | Drug | HCQ Loading dose |
| ChloroquineChloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2 | Drug | CQ regular dose |
| PlaceboStandard of Care plus placebo | Drug | Placebo |
Primary outcome
RT-PCR result
Time frame: 6th and 7th day
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
2 secondary outcomes
Progression of symptoms
Time frame: 7 days
Mortality
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
Ammar Sarwar, MD principal investigator
Beth Israel Deaconess Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxychloroquine Sulfate Regular dose, Hydroxychloroquine Sulfate Loading Dose and Chloroquine in people with Sars-CoV2 and Symptomatic Condition, run by Government of Punjab, Specialized Healthcare and Medical Education Department at 4 sites 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 5 inclusion and 12 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: stopped early, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RT-PCR result (time frame: 6th and 7th day). 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 10 Mar 2021.