COVID-19Phase 4NCT04429867
Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
A Phase 4 study testing Hydroxychloroquine in people with COVID-19, run by WellStar Health System at 1 site in United States.
Trial summary
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2020to 7 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Wellstar Kennestone Hospital
- Age 18 years or older
- Laboratory-confirmed COVID-19
- At least 1 of the following:
- Requiring oxygen supplementation at ≤ 4 liters via nasal cannula or increase from baseline
- Bilateral infiltrates on CXR or CT of chest
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- Age 65 or older
- Diabetes
- Hypertension
- BMI > 35
- Chronic lung disease
- Cardiovascular disease
- Chronic kidney disease
- Cancer (hematologic malignancies, lung cancer, and metastatic disease)
Who cannot join
- Unable to provide informed consent
- Unable to take oral medication
- Severe/critical COVID-19 disease at presentation
- Intensive care or intermediate care required at admission or within 48 hours
- Requiring oxygen supplementation via high flow nasal cannula, bipap, or non-rebreather mask at admission or within 48 hours
- Likelihood of survival <48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
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- Inability to take hydroxychloroquine due to allergy, QTc > 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
- Pregnant or breastfeeding
- Severe liver disease (Child-Pugh Class C)
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
About this study
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Read the detailed description
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, 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 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
PlaceboDrug
Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine | Experimental | Not described Receives: Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
Measured: 30 Days
Secondary outcomes (5)
Hospital length of stay
Measured: 30 Days
30-Day Mortality
Measured: 30 Days
Resolution of Symptoms
Resolution of symptoms will be assessed using standard medical interview procedures with the subject and review of the medical records.
Measured: 14 Days
Incidence of QTc >500ms after initiation of therapy
Measured: 30 Days
Incidence of discontinuation of therapy
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 posted12 Jun 2020
- Study start7 May 2020
- Primary completion7 Dec 2020 (estimated)
- Study completion7 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WellStar Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429867
- Sponsor's protocol ID
- 1604885
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxychloroquine Use in Hospitalized Patients With COVID-19: Impact on Progression to Severe or Critical Disease
- ClinicalTrials.gov ID
- NCT04429867
- Acronym / sponsor ID
- 1604885
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- WellStar Health SystemUniversity, hospital or other
- Study start
- 7 May 2020 (actual)
- Primary completion
- 7 Dec 2020 (estimated)
- Study completion
- 7 Dec 2020 (estimated)
- First posted
- 12 Jun 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.
The primary objective is to assess the impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Detailed description
This study will utilize a randomized, placebo-controlled, double-blinded design. Patients admitted with confirmed COVID-19, and at least 1 of the following: requiring oxygen supplementation (≤4 liters of oxygen via nasal cannula or increase from baseline), bilateral infiltrates on CT/CXR, age >65, diabetes, hypertension, BMI > 35, chronic lung disease, cardiovascular disease, chronic kidney disease, cancer (hematologic malignancies, lung cancer, and metastatic disease), will be randomized in a 1:1 fashion to hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses or placebo at a matching schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine | Experimental | Drug: Hydroxychloroquine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Admitted to Wellstar Kennestone Hospital
- Age 18 years or older
- Laboratory-confirmed COVID-19
- At least 1 of the following:
Key exclusion criteria (9 listed)
- Unable to provide informed consent
- Unable to take oral medication
- Severe/critical COVID-19 disease at presentation
- Likelihood of survival <48 hours in the opinion of the primary physician or transitioned to comfort measures within 48 hours of admission
- Inability to take hydroxychloroquine due to allergy, QTc > 500 ms (male) or 520 ms (female) prior to initiation of hydroxychloroquine, pre-existing retinopathy, known G6PD deficiency, known porphyria, or significant drug- drug interactions
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses | Drug | Hydroxychloroquine |
| PlaceboPlacebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses | Drug | Placebo |
Primary outcome
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease.
Time frame: 30 Days
The impact will be evaluated by comparing rates of a composite primary outcome in patients randomized to hydroxychloroquine versus those randomized to placebo. The composite outcome includes progression to severe/critical disease or death (including withdrawal of care/hospice transfer). Progression to severe/critical disease is defined by requiring oxygen delivery via high flow nasal cannula, non-rebreather mask, bipap, or transfer to intensive care (ICU) or intermediate care units (IMCU) due to COVID-19-related complications.
5 secondary outcomes
Hospital length of stay
Time frame: 30 Days
30-Day Mortality
Time frame: 30 Days
Resolution of Symptoms
Time frame: 14 Days
Incidence of QTc >500ms after initiation of therapy
Time frame: 30 Days
Incidence of discontinuation of therapy
Time frame: 30 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with COVID-19, run by WellStar Health System at 1 site in United States.
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 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 16 Jun 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 United States. 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?
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?
Impact of hydroxychloroquine in hospitalized patients with COVID-19 and risk factors for severe/critical disease. (time frame: 30 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 16 Jun 2020.