COVID-19Phase 3NCT05126628

The South Proxa-Rescue AndroCoV Trial Against COVID-19

A Phase 3 study testing Proxalutamide in people with COVID-19, run by Corpometria Institute at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients. 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?: Proxalutamide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 1 siteBrazil
Study dates: 6 Mar 2021to 15 Apr 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Admitted to the hospital with symptoms of COVID-19 within 7 days
Male and females age ≥18 years old
Laboratory confirmed positive SARS-CoV-2 rtPCR test
Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 3, 4, 5, or 6
Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN
Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
Subject (or legally authorized representative) agree that subject will not participate in another COVID-19 trial while participating in this study

Who cannot join

Subject enrolled in a study to investigate a treatment for COVID-19
Requires mechanical ventilation
Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…
Patients who are allergic to the investigational product or similar drugs (or any excipients);
Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type
Subjects with known serious cardiovascular diseases, congenital long QT syndrome, torsade de pointes, myocardial infarction in the past 6 months, or arterial thrombosis, or unstable angina pectoris, or congestive heart failure which is classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular ejection fraction (LVEF) < 50%, QTcF > 450 ms

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Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, uncontrolled hypothyroidism, uncontrolled diabetes mellitus)
Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory）
Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
Estimated glomerular filtration rate (eGFR) < 30 ml/min
Severe kidney disease requiring dialysis
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective contraception, as shown below, throughout the study and for 3 months after stopping GT0918 treatment. Highly effective contraception methods include:
Total Abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception, or
Use of one of the following combinations (a+b or a+c or b+c):
Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.
Placement of an intrauterine device (IUD) or intrauterine system (IUS) ;
Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository ;
Female sterilization (have had prior surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment ;
Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient;
In case of use of oral contraception women should have been stable for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment, is she considered not of child bearing potential;
Sexually active males that do not to use a condom during intercourse while taking the drug and for 3 months after stopping GT0918 treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid.
Subject likely to transfer to another hospital within the next 28 days
Subject (or legally authorized representative) not willing or unable to provide informed consent

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Corpometria Institute
Brasília, Federal District, 70390-150

Other trials in Brazil

About this study

Official title: Proxalutamide Treatment for Hospitalized COVID-19 Patients in Southern Brazil - The South Proxa-Rescue AndroCoV Trial

The purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.

Conditions: COVID-19
Being tested: Proxalutamide, Placebo
Keywords: COVID-19, SARS-CoV-2, Proxalutamide, Antiandrogens, Anti-androgens, TMPRSS2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProxalutamideDrug
Proxalutamide 300mg q.d.(3 tablets of 100mg each) for 14 days.
PlaceboDrug
Placebo 3 tablets q.d. for 14 days

Study groups in NCT05126628
Study group	Role	What they receive
Active Comparator: Proxalutamide + Usual Care	Active comparator	Proxalutamide + usual care as determined by care provider Receives: Drug: Proxalutamide
Placebo Comparator: Placebo + Usual Care	Placebo comparator	Placebo + usual care as determined by care provider Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

14-Day Recovery Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 14 days after randomization on the COVID-19 ordinal scale.
The ordinal scale is defined as follows:
1. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities
Measured: Day 14

Secondary outcomes (7)

28-Day Recovery Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 28 days after randomization on the COVID-19 ordinal scale.
The ordinal scale is defined as follows:
1. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities
Measured: Day 28
14-Day All-Cause Mortality Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by all-cause mortality rate over 14 days post randomization.
Measured: Day 14
28-Day All-Cause Mortality Rate
Treatment efficacy of proxalutamide relative to placebo as assessed by all-cause mortality rate over 28 days post randomization.
Measured: Day 28
Post-Randomization Time to Recover (Alive Hospital Discharge)
Treatment efficacy of proxalutamide relative to placebo as assessed by number of day post-randomization required to achieve live hospital discharge.
Measured: Day 28
Proportion of subjects needing potent, large-spectrum antibiotics
Defined as the number of subjects who have required vancomycin, meropenem or polymyxin B allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of proxalutamide relative to placebo arm as assessed by the proportion of subjects needing vancomycin, meropenem or polymyxin B in each arm. (%)
Measured: Day 28
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Treatment efficacy of proxalutamide relative to placebo arm as assessed by the rate between the percentage of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 7 after randomization allocated in each arm.
Measured: Day 7
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
Treatment efficacy of proxalutamide relative to placebo arm as assessed by the rate between the percentage of subjects presenting increased d-dimer at Day 7 after randomization allocated in each arm.
Measured: Day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Mar 202115 Apr 2021

First posted19 Nov 2021
Study start6 Mar 2021
Primary completion16 Mar 2021
Study completion15 Apr 2021

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05126628
Sponsor's protocol ID: ProxaSouth
Status last verified: Nov 2021
First submitted: 7 Nov 2021
Last updated: 19 Nov 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Proxalutamide Treatment for Hospitalized COVID-19 Patients in Southern Brazil - The South Proxa-Rescue AndroCoV Trial
ClinicalTrials.gov ID: NCT05126628
Acronym / sponsor ID: ProxaSouth
Conditions: COVID-19
Keywords: COVID-19, SARS-CoV-2, Proxalutamide, Antiandrogens, Anti-androgens, TMPRSS2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Corpometria InstituteUniversity, hospital or other
Collaborators: Hospital da Brigada Militar de Porto Alegre, Porto Alegre, Brazil, Hospital Arcanjo Sao Miguel, Gramado, Brazil, Hospital Unimed Chapeco, Chapeco, Brazil
Study start: 6 Mar 2021 (actual)
Primary completion: 16 Mar 2021 (actual)
Study completion: 15 Apr 2021 (actual)
First posted: 19 Nov 2021 (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 purpose of this study is to investigate the efficacy of proxalutamide or hospitalized moderate-to-severe COVID-19 patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
Model description: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.

Arm	Type	Receives
Active Comparator: Proxalutamide + Usual Care	Active comparator	Drug: ProxalutamideProxalutamide + usual care as determined by care provider
Placebo Comparator: Placebo + Usual Care	Placebo comparator	Drug: PlaceboPlacebo + usual care as determined by care provider

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Admitted to the hospital with symptoms of COVID-19 within 7 days
Male and females age ≥18 years old
Laboratory confirmed positive SARS-CoV-2 rtPCR test
Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 3, 4, 5, or 6
Coagulation: INR ≤ 1.5×ULN, and APTT ≤ 1.5×ULN

Key exclusion criteria (23 listed)

Subject enrolled in a study to investigate a treatment for COVID-19
Requires mechanical ventilation
Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…
Patients who are allergic to the investigational product or similar drugs (or any excipients);
Subjects who have malignant tumors in the past 5 years, with the exception of completed resected basal cell and squamous cell skin cancer and completely resected carcinoma in situ of any type

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
ProxalutamideProxalutamide 300mg q.d.(3 tablets of 100mg each) for 14 days.	Drug	Active Comparator: Proxalutamide + Usual Care
PlaceboPlacebo 3 tablets q.d. for 14 days	Drug	Placebo Comparator: Placebo + Usual Care

Primary outcome

14-Day Recovery Rate
Time frame: Day 14
Treatment efficacy of proxalutamide relative to placebo as assessed by recovery rate defined as those reaching scores 1 or 2 over 14 days after randomization on the COVID-19 ordinal scale. The ordinal scale is defined as follows: 8. Death; 7. Hospitalized, on invasive mechanical ventilation or ECMO; 6. Hospitalized, on non-invasive ventilation or high flow oxygen devices; 5. Hospitalized, requiring supplemental oxygen; 4. Hospitalized, not requiring supplemental oxygen- requiring ongoing medical care (COVID-19 related or otherwise; 3. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 2. Not hospitalized, limitation on activities; 1. Not hospitalized, no limitations on activities

7 secondary outcomes

28-Day Recovery Rate
Time frame: Day 28
14-Day All-Cause Mortality Rate
Time frame: Day 14
28-Day All-Cause Mortality Rate
Time frame: Day 28
Post-Randomization Time to Recover (Alive Hospital Discharge)
Time frame: Day 28
Proportion of subjects needing potent, large-spectrum antibiotics
Time frame: Day 28
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Time frame: Day 7
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
Time frame: Day 7

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.

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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 3 study testing Proxalutamide in people with COVID-19, run by Corpometria Institute at 1 site in Brazil.

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 7 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: finished, as of the sponsor's last update on 19 Nov 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 Brazil. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

14-Day Recovery Rate (time frame: Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05126628.

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 19 Nov 2021.