COVID-19Phase 2RECOVERNCT04374279
Trial to Promote Recovery From COVID-19 With Endocrine Therapy
A Phase 2 study testing Bicalutamide 150 Mg Oral Tablet in people with COVID-19 and SARS-CoV 2, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, SARS-CoV 2
- What is being tested?
- Bicalutamide 150 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2021to Jan 2022
- Phase
- Phase 2
- 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
- ≥18 years of age
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=3 days from enrollment
- Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
- Able to provide informed consent
Who cannot join
- Unable to take oral medication
- Pregnant or breastfeeding
- On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
- Requiring ≥6L oxygen or respiratory rate ≥30
- Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
- Known hypersensitivity to bicalutamide or its components.
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- A past medical history of cirrhosis or AST/ALT/Alk phos/bilirubin > 3x the upper limit of normal
- Patients with a clinical history of myocardial infarction or congestive heart failure within 6 months, or with prior echocardiogram showing ejection fraction < 40%
- Patients currently on coumadin anticoagulants due to the potential for drug-drug interactions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
- Conditions
- COVID-19, SARS-CoV 2
- Being tested
- Bicalutamide 150 Mg Oral Tablet
- Keywords
- COVID-19, Coronavirus, COVID, SARS-COV-2
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicalutamide 150 Mg Oral TabletDrug
Also called Casodex
Bicalutamide 150 mg by mouth daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Standard of care and bicalutamide | Active comparator | Randomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care Receives: Drug: Bicalutamide 150 Mg Oral Tablet |
| Standard of care only | No intervention | Randomized participants receive standard of care only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who have clinical improvement at day 7 after randomization
Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death
Measured: up to 7 days
Secondary outcomes (9)
All-cause mortality
Number of participants deceased for any cause
Measured: 28 days
Duration of hospitalization
Number of calendar days in the hospital
Measured: up to 60 days
Percentage of patients needing upgrade to the intermediate care unit (IMC)
Measured: up to 60 days
Duration of IMC stay
Number of calendar days in IMC
Measured: up to 60 days
Percentage of patients needing upgrade to the intensive care unit (ICU)
Measured: up to 60 days
Duration of ICU stay
Number of calendar days in ICU
Measured: up to 60 days
Number of participants requiring mechanical ventilation
Measured: up to 60 days
Duration of mechanical ventilation
Number of calendar days requiring mechanical ventilation
Measured: up to 60 days
Number of participants experiencing adverse events
Number of participants who are COVID-19 positive, experiencing adverse events as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study startApr 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Why it stopped: Limited resources.
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.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine H Marshall, MD/MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374279
- Sponsor's protocol ID
- COV2003
- Other IDs
- IRB00249425
- Acronym
- RECOVER
- Status last verified
- Mar 2021
- First submitted
- 4 May 2020
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Promote Recovery From COVID-19 With Endocrine Therapy
- ClinicalTrials.gov ID
- NCT04374279
- Acronym / sponsor ID
- RECOVER / COV2003
- Conditions
- COVID-19, SARS-CoV 2
- Keywords
- COVID-19, Coronavirus, COVID, SARS-COV-2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited resources.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 5 May 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.
Patients with COVID-19 requiring inpatient hospitalization will be randomized to treatment with standard of care or standard of care + bicalutamide. This will be a randomized, open-label study to determine if bicalutamide improves the rate of clinical improvement in patients with COVID-19.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 1:1 to bicalutamide with standard of care, or standard of care alone.
| Arm | Type | Receives |
|---|---|---|
| Standard of care and bicalutamide | Active comparator | Drug: Bicalutamide 150 Mg Oral TabletRandomized participants receive bicalutamide 150mg oral for 7 days, plus standard of care |
| Standard of care only | No intervention | –Randomized participants receive standard of care only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- COVID-19 infection, confirmed by polymerase chain reaction (PCR) test <=3 days from enrollment
- Require inpatient hospitalization due to COVID-19 with minimal respiratory symptoms
- Able to provide informed consent
Key exclusion criteria (9 listed)
- Unable to take oral medication
- Pregnant or breastfeeding
- On non-invasive positive pressure ventilation or mechanical ventilation at time of study entry
- Requiring ≥6L oxygen or respiratory rate ≥30
- Taking bicalutamide, any systemic hormonal therapy, or prophylactic treatment for COVID-19 within one month of study entry
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 |
|---|---|---|
| Bicalutamide 150 Mg Oral TabletAlso: CasodexBicalutamide 150 mg by mouth daily for 7 days | Drug | Standard of care and bicalutamide |
Primary outcome
Percentage of participants who have clinical improvement at day 7 after randomization
Time frame: up to 7 days
Percentage of participants who are discharged from the hospital or if they have had at least a 2-point improvement on the World Health Organization (WHO) Ordinal Scale for Clinical Improvement. The WHO clinical improvement scale has a score range of 0-8 where, 0= uninfected, 1= ambulatory with no limitation of activities; 2= ambulatory with limitations to activities; 3= hospitalized, mild disease, with no oxygen therapy; 4= hospitalized, mild disease, with oxygen by mask or nasal prongs; 5= hospitalized, severe disease, with non-invasive ventilation or high-flow oxygen; 6= hospitalized, severe disease, with intubation and mechanical ventilation; 7= hospitalized, severe disease, with ventilation and additional organ support (pressors, dialysis, ECMO); 8= death
9 secondary outcomes
All-cause mortality
Time frame: 28 days
Duration of hospitalization
Time frame: up to 60 days
Percentage of patients needing upgrade to the intermediate care unit (IMC)
Time frame: up to 60 days
Duration of IMC stay
Time frame: up to 60 days
Percentage of patients needing upgrade to the intensive care unit (ICU)
Time frame: up to 60 days
Duration of ICU stay
Time frame: up to 60 days
Number of participants requiring mechanical ventilation
Time frame: up to 60 days
Duration of mechanical ventilation
Time frame: up to 60 days
Number of participants experiencing adverse events
Time frame: up to 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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.
Catherine H Marshall, MD/MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bicalutamide 150 Mg Oral Tablet in people with COVID-19 and SARS-CoV 2, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 4 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: withdrawn, as of the sponsor's last update on 5 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 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Percentage of participants who have clinical improvement at day 7 after randomization (time frame: up to 7 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 5 Mar 2021.