Covid19Phase 2/3NCT04729491
EAT-DUTA AndroCoV Trial
A Phase 2/3 study testing Dutasteride 0.5 mg, Azithromycin and Nitazoxanide in people with Covid19, run by Corpometria Institute at 1 site in Brazil.
Trial summary
During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%). Among children under the age of 14, the rate of severe cases was reported to be extremely low. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Covid19
- What is being tested?
- Dutasteride 0.5 mg, Azithromycin and Nitazoxanide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Jun 2020to 7 Oct 2020
- Phase
- Phase 2/3
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- ≥18 years old
- Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
- Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3
- 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
- Require oxygen use, hospitalization or mechanical ventilation
- Tachycardia (HR > 150 bpm) or hypotension (BP < 90/60 mmHg)
- Patients who are allergic to the investigational product or similar drugs (or any excipients);
- Subjects with QTcF > 450 ms
- Subjects with uncontrolled medical conditions that could compromise participation in the study - uncontrolled hypertension (BP > 220/120 mmHg), uncontrolled hypothyroidism (TSH > 10 iU/L), uncontrolled diabetes mellitus (HbA1c > 12%)
Show all 10Show fewer
- Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
- Estimated glomerular filtration rate (eGFR) < 30 ml/min or requiring dialysis
- Subject (or legally authorized representative) not willing or unable to provide informed consent
- Not willing to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Antiandrogen Treatment (EAT) With Dutasteride for COVID-19 (EAT-DUTA AndroCoV Trial)
During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%). Among children under the age of 14, the rate of severe cases was reported to be extremely low. To explain this difference, several theories have been proposed including cigarette smoking and lifestyle habits. However, no theory fits both the gender difference in severe cases as well as reduced risk in pre-pubescent children. Our past research on male androgenetic alopecia (AGA) has led us to investigate an association between androgens and COVID-19 pathogenesis. In normal subjects, androgen expression demonstrates significant variation between men and women as well as between adults and pre-pubescent children.
SARS-CoV-2 primarily infects type II pneumocytes in the human lung. SARS-CoV-2 enters pneumocytes, by anchoring to the ACE2 cell surface receptor. Prior to receptor binding, viral spike proteins undergo proteolytic priming by the transmembrane protease, serine 2 (TMPRSS2). TMPRSS2 inhibition or knock down reduces ability of SARS-CoV-1 (a related virus to SARS-CoV-2) to infect cells in vitro. Additionally, TMPRSS2 also facilitates entry of influenza A and influenza B into primary human airway cells and type II pneumocytes.
Read more
The human TMPRSS2 gene has a 15 bp androgen response element and in humans, androgens are the only known transcription promoters for the TMPRSS2 gene. In a study of androgen-stimulated prostate cancer cells (LNCaP), TMPRSS2 mRNA expression increase was mediated by the androgen receptor.10 Further, the ACE2 receptor, also critical for SARS-CoV-2 viral infectivity, is affected by male sex hormones with higher activity found in males.
Androgenetic alopecia (AGA), often referred to as male pattern hair loss, is the most common form of hair loss among men. The development of androgenetic alopecia is androgen mediated and is dependent on genetic variants found in the androgen receptor gene located on the X chromosome. We hypothesized that men with AGA would be more prone to severe COVID-19 disease. We conducted a preliminary observational study of hospitalized COVID-19 patients at two Spanish tertiary hospitals between March 23-April 6, 2020 to test this theory. In total, 41 Caucasian males admitted to the hospitals with a diagnosis of bilateral SARS-CoV-2 pneumonia were analyzed. The mean age of patients was 58 years (range 23-79). Among them, 29 (71%) were diagnosed with AGA (16 (39%) were classified as severe AGA (Hamilton IV or above)) and 12 (29%) did not present clinical signs of AGA. The diagnosis of AGA was performed clinically by a dermatologist. The precise prevalence of AGA among otherwise healthy Spanish Caucasian males is unknown; however, based on published literature, the expected prevalence of a similar age-matched Caucasian population is approximately 31-53%.
Further, according to the European Center for Disease Control and Prevention (https://www.ecdc.europa.eu/sites/default/files/documents/covid-19-rapid-risk-assessment-coronavirus-disease-2019-eighth-update-8-april-2020.pdf): "Of the confirmed cases in China, 3.8% (1 716/44 672) were healthcare workers. Of those, 14.8% were severely or critically ill and 5% of the severe cases died. Latest figures reported from Italy show that 9% of COVID-19 cases are healthcare workers, with Lombardy region reporting up to 20% of cases in healthcare workers. In Spain, the latest COVID-19 situation overview from the Ministry of Health reports that 26% of COVID-19 cases are in healthcare workers. In a Dutch study, healthcare workers were tested voluntarily for COVID-19 and 6% tested positive. In a report on 30 cases in healthcare workers in China, all cases had a history of direct contact (distance within 1 metre) with COVID-19 patients, with an average number of 12 contacts, and the average cumulative contact time being two hours (1.5, 2.7). In the Dutch study, only 3% of the healthcare workers reported being exposed to hospital patients with COVID-19 prior onset of symptoms and 63% had worked while asymptomatic.
Based on the scientific rationale combined with this preliminary observation, we propose to test an anti-androgen as a treatment for patients recently diagnosed with COVID-19. This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection, including reduction of virological duration and disease severity.
- Conditions
- Covid19
- Being tested
- Dutasteride 0.5 mg, Azithromycin, Nitazoxanide, Placebo
- Keywords
- SARS-CoV-2, Dutasteride
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutasteride 0.5 mgDrug
Use of dutasteride 0.5mg/day q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects.
AzithromycinDrug
Azithromycin 500mg/day for 05 days
NitazoxanideDrug
500mg twice daily for 06 days
PlaceboDrug
Use of placebo q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects.
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride | Active comparator | Dutasteride 0.5mg/day q.d. for 30 days or until COVID-19 remission (defined as full remission of symptoms plus viral clearance through rtPCR-SARS-CoV-2) Receives: Drug: Dutasteride 0.5 mg; Drug: Azithromycin; Drug: Nitazoxanide |
| Placebo | Placebo comparator | Placebo q.d. for 30 days or until COVID-19 remission (defined as full remission of symptoms plus viral clearance through rtPCR-SARS-CoV-2) Receives: Drug: Azithromycin; Drug: Nitazoxanide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis)
Treatment efficacy of dutasteride relative to placebo arm as assessed by viral load measured by positivity rate (% of positive, detected rtSARS-CoV-2)
Measured: Day 7
Secondary outcomes (42)
World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death]
Treatment efficacy of dutasteride relative to placebo arm as assessed by World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death]
Measured: Day 14
World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death]
Treatment efficacy of dutasteride relative to placebo arm as assessed by World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death]
Measured: Day 7
Time-to-recovery
Recovery is defined as the first day on which the subject satisfies category one from the COVID ordinal scale (defined in Section 5.1): (1) Not hospitalized, no limitations on activities. [Parameter: Number of days until achieve Category 1 of the World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death]
Measured: Day 28
SARS-CoV-2 viral load
Treatment efficacy dutasteride relative to placebo arm as assessed by viral load measured by rtPCR-SARS-CoV-2 (CTs)
Measured: Day 5
Duration of fatigue
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of fatigue (days)
Measured: Day 14
Duration of anosmia
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of anosmia (days)
Measured: Day 14
Overall duration of clinical manifestations
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of overall symptoms (days)
Measured: Day 14
Proportion of subjects needing additional drugs or interventions
Defined as the number of subjects who have required additional drugs (glucocorticoids, anticoagulants, etc) or interventions allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy dutasteride relative to placebo arm as assessed by the proportion of subjects needing additional drugs or interventions in each arm. (%)
Measured: Day 28
Proportion of subjects needing oxygen use
Defined as the number of subjects who have required oxygen use allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of subjects needing oxygen use in each arm. (%)
Measured: Day 28
Proportion of subjects needing high-flow oxygen therapy or non-invasive ventilation
Defined as the number of subjects who have required high-flow oxygen use or non-invasive mechanical ventilation allocated to each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of subjects needing high-flow oxygen use or non-invasive mechanical ventilation in each arm.
Measured: Day 28
Proportion of hospitalizations
Defined as the number of hospitalizations in each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the proportion of hospitalizations in each arm.
Measured: Day 28
Proportion of mechanical ventilation use
Defined as the number of subjects that needed mechanical ventilation in each arm divided by the number of subjects randomized to that specific arm (%). Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of mechanical ventilation use in each arm divided by the number of subjects randomized to that specific arm.
Measured: Day 28
Proportion of vasopressors use
Defined as the number of subjects that needed vasopressors use in each arm divided by the number of subjects randomized to that specific arm (%).Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects needing use of pressors in each arm divided by the number of subjects randomized to that specific arm.
Measured: Day 28
Proportion of deaths
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects who have died in each arm divided by the numbers of subjects randomized to the treatment arm (%).
Measured: Day 60
Duration of new oxygen use
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of new oxygen use measured in days among subjects that did not require oxygen upon randomization and required oxygen use after the beginning of treatment, in each arm (days)
Measured: Day 28
Duration of hospitalization
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of hospitalization measured in days among subjects that required hospitalization, in each arm (days)
Measured: Day 28
Duration of mechanical ventilation
Treatment efficacy of dutasteride relative to placebo arm as assessed by the duration of mechanical ventilation measured in days among subjects that required mechanical ventilation, in each arm (days)
Measured: Day 28
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 1, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 1
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 3, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 3
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased ultrasensitive C-reactive protein (usCRP) at Day 7, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 7
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 1, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 1
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 3, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 3
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting ESR decrease > 50% at Day 7, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 7
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 1, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 1
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 3, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 3
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting eosinophils increase > 50% at Day 7, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 7
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects presenting increased d-dimer protein (usCRP) at Day 7, divided by the number of subjects randomized to that specific arm (%).
Measured: Day 7
Variation in oxygen saturation compared to baseline (Day 0)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 1 compared to baseline (Day 0).
Measured: Day 1
Variation in oxygen saturation compared to baseline (Day 0)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 3 compared to baseline (Day 0).
Measured: Day 3
Variation in oxygen saturation compared to baseline (Day 0)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 5 compared to baseline (Day 0).
Measured: Day 5
Variation in oxygen saturation compared to baseline (Day 0)
Treatment efficacy of dutasteride relative to placebo arm as assessed by the mean variation of oxygen saturation of subjects randomized to that specific arm (%) at Day 7 compared to baseline (Day 0).
Measured: Day 7
Disease duration
Treatment efficacy of dutasteride relative to placebo arm as assessed by duration of symptoms, complications, or any other COVID-related clinical or biochemical sign of disease (days)
Measured: Day 30
Change in viral load from baseline to Day 5
Treatment efficacy of dutasteride relative to placebo arm as assessed by change in viral load from baseline to Day 5 measured by rtPCR-SARS-CoV-2 (CTs)
Measured: Day 5
Proportion of post-COVID mental symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30.
Measured: Day 30
Proportion of post-COVID physical symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30.
Measured: Day 30
Proportion of post-COVID overall symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 30.
Measured: Day 30
Proportion of post-COVID mental symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60.
Measured: Day 60
Proportion of post-COVID physical symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60.
Measured: Day 60
Proportion of post-COVID overall symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 60.
Measured: Day 60
Proportion of post-COVID mental symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with mental symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90.
Measured: Day 90
Proportion of post-COVID physical symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with physical symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90.
Measured: Day 90
Proportion of post-COVID overall symptoms
Treatment efficacy of dutasteride relative to placebo arm as assessed by the number of subjects persisting with any symptoms after COVID-19 resolution in each arm divided by the number of subjects randomized to that specific arm (%) at Day 90.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start30 Jun 2020
- Primary completion15 Sep 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corpometria Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos G. Wambier, MD, Ph.D., Study director, Alpert School of Medicine - Brown UniversityFlavio A. Cadegiani, MD, MSc, Ph.D., Principal investigator, Corpometria InstituteAndy Goren, MD, Study chair, Applied Biology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729491
- Sponsor's protocol ID
- CORPO-AB-DRUG-SARS-004B
- Status last verified
- Jun 2020
- First submitted
- 25 Jan 2021
- Last updated
- 28 Jan 2021
- 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 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Antiandrogen Treatment (EAT) With Dutasteride for COVID-19 (EAT-DUTA AndroCoV Trial)
- ClinicalTrials.gov ID
- NCT04729491
- Acronym / sponsor ID
- CORPO-AB-DRUG-SARS-004B
- Conditions
- Covid19
- Keywords
- SARS-CoV-2, Dutasteride
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Corpometria InstituteUniversity, hospital or other
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 28 Jan 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.
During the continuing SARS-CoV-2 (COVID-19) pandemic, several studies have reported a significant difference in the rate of severe cases between adult females and adult males (42% vs 58%). Among children under the age of 14, the rate of severe cases was reported to be extremely low. To explain this difference, several theories have been proposed including cigarette smoking and lifestyle habits. However, no theory fits both the gender difference in severe cases as well as reduced risk in pre-pubescent children. Our past research on male androgenetic alopecia (AGA) has led us to investigate an association between androgens and COVID-19 pathogenesis. In normal subjects, androgen expression demonstrates significant variation between men and women as well as between adults and pre-pubescent children.
SARS-CoV-2 primarily infects type II pneumocytes in the human lung. SARS-CoV-2 enters pneumocytes, by anchoring to the ACE2 cell surface receptor. Prior to receptor binding, viral spike proteins undergo proteolytic priming by the transmembrane protease, serine 2 (TMPRSS2). TMPRSS2 inhibition or knock down reduces ability of SARS-CoV-1 (a related virus to SARS-CoV-2) to infect cells in vitro. Additionally, TMPRSS2 also facilitates entry of influenza A and influenza B into primary human airway cells and type II pneumocytes.
The human TMPRSS2 gene has a 15 bp androgen response element and in humans, androgens are the only known transcription promoters for the TMPRSS2 gene. In a study of androgen-stimulated prostate cancer cells (LNCaP), TMPRSS2 mRNA expression increase was mediated by the androgen receptor.10 Further, the ACE2 receptor, also critical for SARS-CoV-2 viral infectivity, is affected by male sex hormones with higher activity found in males.
Androgenetic alopecia (AGA), often referred to as male pattern hair loss, is the most common form of hair loss among men. The development of androgenetic alopecia is androgen mediated and is dependent on genetic variants found in the androgen receptor gene located on the X chromosome. We hypothesized that men with AGA would be more prone to severe COVID-19 disease. We conducted a preliminary observational study of hospitalized COVID-19 patients at two Spanish tertiary hospitals between March 23-April 6, 2020 to test this theory. In total, 41 Caucasian males admitted to the hospitals with a diagnosis of bilateral SARS-CoV-2 pneumonia were analyzed. The mean age of patients was 58 years (range 23-79). Among them, 29 (71%) were diagnosed with AGA (16 (39%) were classified as severe AGA (Hamilton IV or above)) and 12 (29%) did not present clinical signs of AGA. The diagnosis of AGA was performed clinically by a dermatologist. The precise prevalence of AGA among otherwise healthy Spanish Caucasian males is unknown; however, based on published literature, the expected prevalence of a similar age-matched Caucasian population is approximately 31-53%.
Further, according to the European Center for Disease Control and Prevention (https://www.ecdc.europa.eu/sites/default/files/documents/covid-19-rapid-risk-assessment-coronavirus-disease-2019-eighth-update-8-april-2020.pdf): "Of the confirmed cases in China, 3.8% (1 716/44 672) were healthcare workers. Of those, 14.8% were severely or critically ill and 5% of the severe cases died. Latest figures reported from Italy show that 9% of COVID-19 cases are healthcare workers, with Lombardy region reporting up to 20% of cases in healthcare workers. In Spain, the latest COVID-19 situation overview from the Ministry of Health reports that 26% of COVID-19 cases are in healthcare workers. In a Dutch study, healthcare workers were tested voluntarily for COVID-19 and 6% tested positive. In a report on 30 cases in healthcare workers in China, all cases had a history of direct contact (distance within 1 metre) with COVID-19 patients, with an average number of 12 contacts, and the average cumulative contact time being two hours (1.5, 2.7). In the Dutch study, only 3% of the healthcare workers reported being exposed to hospital patients with COVID-19 prior onset of symptoms and 63% had worked while asymptomatic.
Based on the scientific rationale combined with this preliminary observation, we propose to test an anti-androgen as a treatment for patients recently diagnosed with COVID-19. This study is intended to explore the possible protective role of anti-androgens in SARS-CoV-2 infection, including reduction of virological duration and disease severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dutasteride | Active comparator | Drug: Dutasteride 0.5 mg, Drug: Azithromycin, Drug: NitazoxanideDutasteride 0.5mg/day q.d. for 30 days or until COVID-19 remission (defined as full remission of symptoms plus viral clearance through rtPCR-SARS-CoV-2) |
| Placebo | Placebo comparator | Drug: Azithromycin, Drug: Nitazoxanide, Drug: PlaceboPlacebo q.d. for 30 days or until COVID-19 remission (defined as full remission of symptoms plus viral clearance through rtPCR-SARS-CoV-2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male
- ≥18 years old
- Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to randomization
- Clinical status on the COVID-19 Ordinal Scale (defined in Section 5.1) of 1 to 3
- Subject (or legally authorized representative) gives written informed consent prior to performing any study procedures
Key exclusion criteria (10 listed)
- Subject enrolled in a study to investigate a treatment for COVID-19
- Require oxygen use, hospitalization or mechanical ventilation
- Tachycardia (HR > 150 bpm) or hypotension (BP < 90/60 mmHg)
- Patients who are allergic to the investigational product or similar drugs (or any excipients);
- Subjects with QTcF > 450 ms
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 |
|---|---|---|
| Dutasteride 0.5 mgUse of dutasteride 0.5mg/day q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects. | Drug | Dutasteride |
| AzithromycinAzithromycin 500mg/day for 05 days | Drug | Dutasteride, Placebo |
| Nitazoxanide500mg twice daily for 06 days | Drug | Dutasteride, Placebo |
| PlaceboUse of placebo q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects. | Drug | Placebo |
Primary outcome
Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis)
Time frame: Day 7
Treatment efficacy of dutasteride relative to placebo arm as assessed by viral load measured by positivity rate (% of positive, detected rtSARS-CoV-2)
42 secondary outcomes
World Health Organization (WHO) Clinical Progression Scale [0 to 10; 0 = uninfected; 10 = death]
Time frame: Day 14
World Health Organization (WHO) COVID=19 Ordinal Scale for Clinical Improvement [1 to 8; 1 = not hospitalized, no limitation on activities; 8 = death]
Time frame: Day 7
Time-to-recovery
Time frame: Day 28
SARS-CoV-2 viral load
Time frame: Day 5
Duration of fatigue
Time frame: Day 14
Duration of anosmia
Time frame: Day 14
Overall duration of clinical manifestations
Time frame: Day 14
Proportion of subjects needing additional drugs or interventions
Time frame: Day 28
Proportion of subjects needing oxygen use
Time frame: Day 28
Proportion of subjects needing high-flow oxygen therapy or non-invasive ventilation
Time frame: Day 28
Proportion of hospitalizations
Time frame: Day 28
Proportion of mechanical ventilation use
Time frame: Day 28
Proportion of vasopressors use
Time frame: Day 28
Proportion of deaths
Time frame: Day 60
Duration of new oxygen use
Time frame: Day 28
Duration of hospitalization
Time frame: Day 28
Duration of mechanical ventilation
Time frame: Day 28
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Time frame: Day 1
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Time frame: Day 3
Proportion of increased ultrasensitive C-reactive protein (usCRP) (defined as usRCP > 7 mg/L)
Time frame: Day 7
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Time frame: Day 1
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Time frame: Day 3
Proportion of decrease in erythrocyte sedimentation rate (ESR) (defined as ESR decrease > 50% compared to baseline (Day 0))
Time frame: Day 7
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Time frame: Day 1
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Time frame: Day 3
Proportion of increase in eosinophils (defined as eosinophils increase > 50% compared to baseline (Day 0))
Time frame: Day 7
Proportion of increased d-dimer (defined as d-dimer > 500 mg/dL)
Time frame: Day 7
Variation in oxygen saturation compared to baseline (Day 0)
Time frame: Day 1
Variation in oxygen saturation compared to baseline (Day 0)
Time frame: Day 3
Variation in oxygen saturation compared to baseline (Day 0)
Time frame: Day 5
Variation in oxygen saturation compared to baseline (Day 0)
Time frame: Day 7
Disease duration
Time frame: Day 30
Change in viral load from baseline to Day 5
Time frame: Day 5
Proportion of post-COVID mental symptoms
Time frame: Day 30
Proportion of post-COVID physical symptoms
Time frame: Day 30
Proportion of post-COVID overall symptoms
Time frame: Day 30
Proportion of post-COVID mental symptoms
Time frame: Day 60
Proportion of post-COVID physical symptoms
Time frame: Day 60
Proportion of post-COVID overall symptoms
Time frame: Day 60
Proportion of post-COVID mental symptoms
Time frame: Day 90
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 28 Jan 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.
Carlos G. Wambier, MD, Ph.D. study director
Alpert School of Medicine - Brown University
Flavio A. Cadegiani, MD, MSc, Ph.D. principal investigator
Corpometria Institute
Andy Goren, MD study chair
Applied Biology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dutasteride 0.5 mg, Azithromycin and Nitazoxanide in people with Covid19, 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 6 inclusion and 10 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 28 Jan 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 combined 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.
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?
Positivity rate of rtPCR-SARS-CoV-2 (qualitative analysis) (time frame: Day 7). 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 28 Jan 2021.