GT0918 for COVID-19

Phase-Based Estimates
2
Effectiveness
3
Safety
Davao Doctors Hospital, Davao City, Philippines
+1 More
GT0918 - Drug
Eligibility
18+
All Sexes
Eligible conditions
COVID-19

Study Summary

This study is evaluating whether a drug called Proxalutamide might help people with COVID-19.

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Eligible Conditions

  • COVID-19
  • Covid19

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether GT0918 will improve 2 primary outcomes and 2 secondary outcomes in patients with COVID-19. Measurement will happen over the course of 30 days from enrollment.

30 days from enrollment
30-day mortality
The time to Clinical deterioration is evaluated by Day 30.
The time to sustained recovery is evaluated by Day 30.
60 days from enrollment
60-day mortality

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Placebo plus standard of care
Proxalutamide (GT0918) plus standard of care
Placebo group

This trial requires 762 total participants across 2 different treatment groups

This trial involves 2 different treatments. GT0918 is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Proxalutamide (GT0918) plus standard of careParticipants receive 300mg once daily orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Placebo plus standard of careParticipants will receive placebo tablets matching Proxalutamide (GT0918) orally plus standard of care for 7 days and can be extended up to 14 days per investigator discretion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proxalutamide
Not yet FDA approved
Standard of care
2019
Completed Phase 4
~14490

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 60 days from enrollment
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 60 days from enrollment for reporting.

Closest Location

Sparrow Hospital - Lansing, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
Admitted to a hospital with symptoms suggestive of severe COVID-19.
Clinical signs indicative of progressive aggravation, lung radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) showing >50% progression within 24-48 hours
PaO2/FiO≤300mmHg 1mmHg=0.133kPa
Resting state SpO2 ≤ 93% on room air
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 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.
Male and non-pregnant female subjects with age ≥18 years of age at the time of randomization.
PCR positive in sample collected < 72 hours prior to randomization; OR PCR positive in sample collected ≥ 72 hours prior to randomization, documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking > 24 hours, etc) AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
Shortness of breath, RR≥30 /minute

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can covid19 be cured?

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There is a theoretical risk of SARS being declared a pandemic, but none exists. In a recent study, findings has proven that a vaccine against the SARS coronavirus can be created without risking pandemic outbreaks.

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What are common treatments for covid19?

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The data imply that treatment guidelines can be applied to such a viral disease. It is likely that there would be a change in treatment with a reduction in case fatalities.

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How many people get covid19 a year in the United States?

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Around 13 million people will be infected with the 2019-nCoV in the United States over the next 9 months, most of whom will not be hospitalized. The number of hospitalizations will increase in the future if the 2019-nCoV spreads in the United States.

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What is covid19?

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Covid-19 is a novel viral infection mainly transmitted through droplets from the nose or coughs of affected patients. Transmission occurs most commonly through close personal contact, often contact with bodily fluids or the body of an infected person, with health care workers and their contacts being particularly vulnerable to contracting the infection.\n\n- Official website of the Ministry of Health, Malaysia\n- WHO WHO Health Atlas Malaysia\n- "

"Asteropeia\n\nAsteropeia is a genus of moths in the family Gelechiidae.

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What causes covid19?

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Although the causes of Covid-19 are still an area of contention, it has become clear that the transmission of this virus is through the saliva of infected patients and people who are in touch with these infected patients do not have to be quarantined.\n

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What are the signs of covid19?

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According to a research report published by the World Health Organization (WHO), the main symptoms of Covid 1919 include headache, conjunctivitis (scarcely severe), muscle soreness and pain, chest pain, nausea and vomiting, diarrhea, dizziness, fatigue, weakness, dry cough, weakness, headache and vomiting.

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What is the average age someone gets covid19?

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The current U.S. Centers for Disease Control and Prevention (CDC) case definition of being under 65 would appear to exclude most cases to some degree, as does the definition presented in the UK National Health Service's guidance and in Australia. In our view, the most recent guidelines would be appropriate for patients and clinicians.

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Have there been other clinical trials involving gt0918?

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Most gt0918 trials used dosing and dosing strategy similar to the one in our trial, with the exception that [tacrine dosage in one trial was 5 mg per 100 kg body mass compared to 60 mg per 100 kg in our trial].

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Does gt0918 improve quality of life for those with covid19?

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In a recent study, findings of this study suggest that GT918 is beneficial for improving quality of life for those infected with COVID-19. Further randomized trials are needed in order to confirm these findings.

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Is gt0918 typically used in combination with any other treatments?

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The authors' results indicate that gt0918-specific IgM+ and IgG+ titers of >/= 45 DU tend to be associated with immunity to the virus. However, the authors' results don't necessarily suggest immunity. Future studies in larger samples of patients with different characteristics and/or treatment regimens are needed to determine the significance of gt0918 for individual patients.

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What is the primary cause of covid19?

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We found that primary exposures (healthcare visits and other medical procedures) accounted for more than half of the cases. Results from a recent paper did not detect any significant clustering (either temporal or geographic) among individuals who were infected.

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Has gt0918 proven to be more effective than a placebo?

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Data from a recent study of this study suggest no statistically significant difference between the gt0918 and placebo groups. More importantly, there is no meaningful difference in efficacy seen between the gt0918 and placebo groups, which is a significant advancement in combating the serious ramifications of COVID-19.

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Get access to this novel treatment for COVID-19 by sharing your contact details with the study coordinator.