Corticosteroid for COVID-19

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
COVID-19+6 More
Corticosteroid - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing different drugs to see if they are effective and safe in treating COVID-19 in people who are hospitalized and have acute respiratory failure.

Eligible Conditions
  • COVID-19
  • Covid19

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 25 Secondary · Reporting Duration: Days 1-7, 14 and 28

14 days
Incidence of no home use of supplemental oxygen above pre-morbid oxygen use
Day 90
In category 4, 5 or 6 at Day 90 vs. in categories 1-3 at Day 90
In category 5 or 6 at Day 90 vs. in categories 1-4 at Day 90
Day 1
Pulmonary ordinal outcome
Thru Day 180
Composite of SAEs or death
Composite of hospital readmissions or death
Incidence of home use of supplemental oxygen above pre-morbid oxygen use
Incidence of infusion reactions
Time to hospital discharge from initial hospitalization
Thru Day 28
Incidence of clinical organ failure
Incidence of clinical organ failure or serious infections
Thru Day 90
All-cause mortality
Composite of alive, at home and off new supplemental oxygen
Composite of cardiovascular events and thromboembolic events
Composite of death or serious clinical COVID-19 related events
Composite of death, clinical organ failure or serious infections
Composite of recovered, alive and not recovered, and dead
Composite of time to recovery, days at home off new supplemental oxygen and time to death
Composite of time to recovery, free/not free of respiratory support and mortality
Percentage of participants for whom infusion was interrupted or stopped prior to completion due to adverse event
Percentage of participants for whom infusion was interrupted or stopped prior to completion for any reason
Recovery, assessed at 90 days
Time from randomization to recovery
Time to death
Day 5
Composite of grade 3 and 4 clinical adverse events, serious adverse events (SAEs) or death
Up to Day 90
Days alive outside short-term acute care hospital

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Induction Phase: Cyclophosphamide
46%Nausea
38%Vomiting
36%Alopecia
26%Headache
24%Arthralgia
21%Leukopenia
17%Pyrexia
17%Oedema peripheral
16%Nasopharyngitis
16%Upper respiratory tract infection
14%Hypertension
13%Diarrhoea
12%Rash
10%Fatigue
10%Abdominal pain upper
9%Oedema
9%Urinary tract infection
9%Back pain
9%Cough
9%White blood cell count decreased
8%Asthenia
7%Abdominal pain
7%Neutropenia
7%Anaemia
6%Chest pain
6%Insomnia
6%Arthritis
6%Erythema
6%Cushingoid
6%Dizziness
5%Constipation
5%Acne
5%Pain in extremity
3%Herpes zoster
3%Dyspnoea
3%Dyspepsia
3%Palpitations
3%Tachycardia
2%Pneumonia
2%Systemic lupus erythematosus
2%Convulsion
2%Hypokalaemia
1%Pharyngolaryngeal pain
1%Lupus pneumonitis
1%Pericardial effusion
1%Hypoalbuminaemia
1%Panniculitis
1%Death
1%Uterine haemorrhage
1%Gingivitis
1%Meningitis bacterial
1%Nephrotic syndrome
1%Subclavian vein thrombosis
1%Infection
1%Herpes simplex
1%Respiratory tract infection
1%Gastroenteritis viral
1%Abdominal distension
1%Cardiac arrest
1%Hyperkalaemia
1%Rash maculo-papular
1%Deep vein thrombosis
1%Psychotic disorder
1%Anaphylactic reaction
1%Dermatitis exfoliative
1%Bronchitis
1%Lobar pneumonia
1%Myositis
1%Costochondritis
1%Lupus encephalitis
1%Syncope
1%Blood creatinine increased
1%Gastrointestinal infection
1%Cerebrovascular accident
1%Venous stenosis
1%International normalised ratio increased
1%Alanine aminotransferase increased
1%Cellulitis
1%Tonsillitis
1%Subacute endocarditis
1%Biopsy kidney
1%Hepatic function abnormal
1%Renal failure
1%Renal failure chronic
1%Thrombocytopenia
This histogram enumerates side effects from a completed 2010 Phase 3 trial (NCT00377637) in the Induction Phase: Cyclophosphamide ARM group. Side effects include: Nausea with 46%, Vomiting with 38%, Alopecia with 36%, Headache with 26%, Arthralgia with 24%.

Trial Design

4 Treatment Groups

Aviptadil Placebo + Remdesivir + SOC
1 of 4
Aviptadil Placebo + Remdesivir Placebo + SOC
1 of 4
Aviptadil + Remdesivir + SOC
1 of 4
Aviptadil + Remdesivir Placebo + SOC
1 of 4

Experimental Treatment

Non-Treatment Group

473 Total Participants · 4 Treatment Groups

Primary Treatment: Corticosteroid · Has Placebo Group · Phase 3

Aviptadil Placebo + Remdesivir + SOCExperimental Group · 3 Interventions: Remdesivir, Aviptadil Placebo, Corticosteroid · Intervention Types: Biological, Drug, Drug
Aviptadil Placebo + Remdesivir Placebo + SOCExperimental Group · 3 Interventions: Remdesivir Placebo, Aviptadil Placebo, Corticosteroid · Intervention Types: Drug, Drug, Drug
Aviptadil + Remdesivir + SOCExperimental Group · 3 Interventions: Remdesivir, Corticosteroid, Aviptadil · Intervention Types: Biological, Drug, Biological
Aviptadil + Remdesivir Placebo + SOCPlaceboComparator Group · 3 Interventions: Remdesivir Placebo, Corticosteroid, Aviptadil · Intervention Types: Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remdesivir
FDA approved
Corticosteroid
2005
Completed Phase 4
~2100

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 1-7, 14 and 28

Who is running the clinical trial?

Washington D.C. Veterans Affairs Medical CenterFED
32 Previous Clinical Trials
15,384 Total Patients Enrolled
2 Trials studying COVID-19
3,393 Patients Enrolled for COVID-19
Gilead SciencesIndustry Sponsor
1,010 Previous Clinical Trials
654,778 Total Patients Enrolled
17 Trials studying COVID-19
17,531 Patients Enrolled for COVID-19
NeuroRx, Inc.Industry Sponsor
10 Previous Clinical Trials
20,662 Total Patients Enrolled
2 Trials studying COVID-19
20,196 Patients Enrolled for COVID-19
University of CopenhagenOTHER
816 Previous Clinical Trials
12,277,812 Total Patients Enrolled
5 Trials studying COVID-19
3,649 Patients Enrolled for COVID-19
Medical Research CouncilOTHER_GOV
298 Previous Clinical Trials
1,945,362 Total Patients Enrolled
5 Trials studying COVID-19
6,743 Patients Enrolled for COVID-19
Prevention and Early Treatment of Acute Lung Injury (PETAL)UNKNOWN
2 Previous Clinical Trials
3,393 Total Patients Enrolled
2 Trials studying COVID-19
3,393 Patients Enrolled for COVID-19
US Department of Veterans AffairsFED
853 Previous Clinical Trials
470,398 Total Patients Enrolled
3 Trials studying COVID-19
3,413 Patients Enrolled for COVID-19
Kirby InstituteOTHER_GOV
98 Previous Clinical Trials
134,456 Total Patients Enrolled
5 Trials studying COVID-19
4,336 Patients Enrolled for COVID-19
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT)NETWORK
6 Previous Clinical Trials
5,267 Total Patients Enrolled
4 Trials studying COVID-19
4,806 Patients Enrolled for COVID-19
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,577 Previous Clinical Trials
46,968,117 Total Patients Enrolled
13 Trials studying COVID-19
69,108 Patients Enrolled for COVID-19
Cardiothoracic Surgical Trials Network (CTSN)UNKNOWN
2 Previous Clinical Trials
3,393 Total Patients Enrolled
2 Trials studying COVID-19
3,393 Patients Enrolled for COVID-19
AIDS Clinical Trials GroupNETWORK
89 Previous Clinical Trials
69,076 Total Patients Enrolled
3 Trials studying COVID-19
7,437 Patients Enrolled for COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,130 Previous Clinical Trials
4,933,591 Total Patients Enrolled
69 Trials studying COVID-19
288,987 Patients Enrolled for COVID-19
Prof. James NeatonStudy ChairINSIGHT Statistical and Coordinating Centre, University of Minnesota
1 Previous Clinical Trials
2,753 Total Patients Enrolled
1 Trials studying COVID-19
2,753 Patients Enrolled for COVID-19
Samuel Brown, MDPrincipal InvestigatorIntermountain Medical Center/University of Utah
3 Previous Clinical Trials
274 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The person has been infected with the SARS-CoV-2 virus (COVID-19) within the past two weeks.
Having to go to a hospital for acute medical care.
Respiratory failure that is currently being treated with high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ECMO.
The cause of respiratory failure is believed to be SARS-CoV-2 pneumonia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 11th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place50.0%
Montefiore Medical Center - Moses campus (Site 206-003), 111 E. 210th Street50.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria33.3%
Met criteria66.7%