Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04728802
Previous Study | Return to List | Next Study

Proxalutamide Treatment for Hospitalized COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04728802
Recruitment Status : Completed
First Posted : January 28, 2021
Results First Posted : June 23, 2021
Last Update Posted : June 24, 2021
Sponsor:
Information provided by (Responsible Party):
Applied Biology, Inc.

Brief Summary:
The purpose of this study is to assess the efficacy and safety of Proxalutamide as a treatment for hospitalized COVID-19 male and female patients.

Condition or disease Intervention/treatment Phase
Covid19 SARS (Severe Acute Respiratory Syndrome) Drug: Proxalutamide Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is designed as a prospective, interventional, placebo controlled, double-blinded, randomized parallel assignment study.
Masking: Double (Participant, Care Provider)
Masking Description: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Proxalutamide Treatment for Hospitalized COVID-19 Patients
Actual Study Start Date : February 1, 2021
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Proxalutamide + Usual Care
Proxalutamide + usual care as determined by care provider
Drug: Proxalutamide
Proxalutamide 300mg q.d

Placebo Comparator: Placebo + Usual Care
Placebo + usual care as determined by care provider
Drug: Placebo
Placebo pill




Primary Outcome Measures :
  1. 14 Day Recovery Rate [ Time Frame: Day 14 ]

    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



Secondary Outcome Measures :
  1. 28 Day Recovery Rate [ Time Frame: Day 28 ]

    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:

    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


  2. 28 Day Mortality Rate [ Time Frame: 28 days ]
    All-cause mortality rate over 28 days post randomization.

  3. Post-Randomization Time to Recover (Alive Hospital Discharge) [ Time Frame: 28 days ]
    Number of day post-randomization required to achieve live hospital discharge.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Subject enrolled in a study to investigate a treatment for COVID-19
  2. Requires mechanical ventilation
  3. Subject taking an anti-androgen of any type including: androgen depravation therapy, 5-alpha reductase inhibitors, etc…
  4. Patients who are allergic to the investigational product or similar drugs (or any excipients);
  5. 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
  6. 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
  7. Subjects with uncontrolled medical conditions that could compromise participation in the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)
  8. Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis B, treponema pallidum (testing is not mandatory)
  9. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal.
  10. Estimated glomerular filtration rate (eGFR) < 30 ml/min
  11. Severe kidney disease requiring dialysis
  12. 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):

      1. 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.
      2. Placement of an intrauterine device (IUD) or intrauterine system (IUS) ;
      3. 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;
  13. Sexually active males must 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
  14. Subject likely to transfer to another hospital within the next 28 days
  15. Subject (or legally authorized representative) not willing or unable to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04728802


Locations
Layout table for location information
Brazil
Hospital Regional José Mendes
Itacoatiara, Amazonas, Brazil
Hospital de Campanha de Manacapuru
Manacapuru, Amazonas, Brazil
Hospital Oscar Nicolau
Manaus, Amazonas, Brazil
Hospital Prontocord
Manaus, Amazonas, Brazil
Hospital Samel
Manaus, Amazonas, Brazil
Hospital Regional Dr. Hamilton Maia Cidae
Manicore, Amazonas, Brazil
Hospital Raimunda Francisca Dinelli da Silva
Maues, Amazonas, Brazil
Hospital Regional Jofre Cohen
Parintins, Amazonas, Brazil
Sponsors and Collaborators
Applied Biology, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Flavio Cadegiani, MD Applied Biology, Inc.
Study Director: Andy Goren, MD Applied Biology, Inc.
  Study Documents (Full-Text)

Documents provided by Applied Biology, Inc.:
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Applied Biology, Inc.
ClinicalTrials.gov Identifier: NCT04728802    
Other Study ID Numbers: KP-DRUG-SARS-003
First Posted: January 28, 2021    Key Record Dates
Results First Posted: June 23, 2021
Last Update Posted: June 24, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Yes, study data sets will be made available upon request after peer review and publication.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Available upon request after peer review and publication.
Access Criteria: Available upon request at data@appliedbiology.com

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Applied Biology, Inc.:
Proxalutamide
Androgen
Anti-androgen
Additional relevant MeSH terms:
Layout table for MeSH terms
Severe Acute Respiratory Syndrome
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases