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Corticosteroid for Coronavirus (TESICO Trial)

Phase 3
Waitlist Available
Led By Samuel Brown, MD
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-7, 14 and 28
Awards & highlights

TESICO Trial 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
  • Coronavirus

TESICO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-7, 14 and 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1-7, 14 and 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recovery, assessed at 90 days
Secondary outcome measures
All-cause mortality
Composite of SAEs or death
Composite of alive, at home and off new supplemental oxygen
+20 more

Side effects data

From 2010 Phase 3 trial • 370 Patients • NCT00377637
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%
Back pain
9%
Urinary tract infection
9%
White blood cell count decreased
9%
Oedema
9%
Cough
8%
Asthenia
7%
Abdominal pain
7%
Anaemia
7%
Neutropenia
6%
Arthritis
6%
Chest pain
6%
Insomnia
6%
Cushingoid
6%
Erythema
6%
Dizziness
5%
Pain in extremity
5%
Acne
5%
Constipation
3%
Dyspnoea
3%
Herpes zoster
3%
Palpitations
3%
Tachycardia
3%
Dyspepsia
2%
Hypokalaemia
2%
Systemic lupus erythematosus
2%
Convulsion
2%
Pneumonia
1%
Subacute endocarditis
1%
Subclavian vein thrombosis
1%
Tonsillitis
1%
Nephrotic syndrome
1%
Bronchitis
1%
Lobar pneumonia
1%
Herpes simplex
1%
Respiratory tract infection
1%
Hyperkalaemia
1%
Hypoalbuminaemia
1%
Cardiac arrest
1%
Pericardial effusion
1%
Death
1%
Deep vein thrombosis
1%
Venous stenosis
1%
Hepatic function abnormal
1%
Anaphylactic reaction
1%
Costochondritis
1%
Myositis
1%
Infection
1%
Cerebrovascular accident
1%
Syncope
1%
Psychotic disorder
1%
Lupus encephalitis
1%
Uterine haemorrhage
1%
Biopsy kidney
1%
Gastrointestinal infection
1%
Gastroenteritis viral
1%
Cellulitis
1%
Meningitis bacterial
1%
Abdominal distension
1%
Gingivitis
1%
Renal failure
1%
Renal failure chronic
1%
Thrombocytopenia
1%
Lupus pneumonitis
1%
Pharyngolaryngeal pain
1%
International normalised ratio increased
1%
Alanine aminotransferase increased
1%
Blood creatinine increased
1%
Dermatitis exfoliative
1%
Panniculitis
1%
Rash maculo-papular
100%
80%
60%
40%
20%
0%
Study treatment Arm
Induction Phase: Cyclophosphamide
Induction Phase: Mycophenolate Mofetil
Maintenance Phase: Mycophenolate Mofetil
Maintenance Phase: Azathioprine

TESICO Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Aviptadil Placebo + Remdesivir Placebo + SOCExperimental Treatment3 Interventions
Group II: Aviptadil Placebo + Remdesivir + SOCExperimental Treatment3 Interventions
Group III: Aviptadil + Remdesivir + SOCExperimental Treatment3 Interventions
Group IV: Aviptadil + Remdesivir Placebo + SOCPlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aviptadil Placebo
2021
Completed Phase 3
~480
Corticosteroid
2005
Completed Phase 4
~2210
Remdesivir
2020
Completed Phase 3
~21440
Remdesivir Placebo
2021
Completed Phase 3
~480
Aviptadil
2021
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

Cardiothoracic Surgical Trials Network (CTSN)UNKNOWN
8 Previous Clinical Trials
5,851 Total Patients Enrolled
Prevention and Early Treatment of Acute Lung Injury (PETAL)UNKNOWN
8 Previous Clinical Trials
5,851 Total Patients Enrolled
NeuroRx, Inc.Industry Sponsor
12 Previous Clinical Trials
686 Total Patients Enrolled

Frequently Asked Questions

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

Has this particular research been conducted before?

"Clinical trials for corticosteroid began in 2020. The first Phase 3 2900-person study was sponsored by AbbVie and occurred in 2020. 12 different trials are currently underway in 36 countries and 184 cities."

Answered by AI

Are recruitment efforts for this research underway at the moment?

"Despite being posted on clinicaltrials.gov, this particular study is not looking for volunteers at the moment. The trial was first advertised on 4/20/2021, with the latest update on 11/7/2022. Although this study isn't currently running, there are 1154 other clinical trials that are."

Answered by AI

Has the FDA greenlit Corticosteroid for public use?

"Corticosteroid's safety is relatively well-known because it has gone through multiple Phase 3 trials."

Answered by AI

Which medical conditions are typically treated by taking Corticosteroids?

"Corticosteroid is a medication given to patients that weigh between 3.5 and 40 kg. It is also used to treat other conditions, like when a patient's spo2 is ≤ 94% or they require supplemental oxygen, and if the patient is hospitalized."

Answered by AI

Are there any other examples of research done on Corticosteroid?

"Corticosteroid was first studied in 2020 at Island Health - Victoria General Hospital. As of now, there have been 58 completed studies with 12 more currently underway - many of which are based in Springfield, Massachusetts."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Mount Sinai Medical Center (Site 301-012), Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place
Montefiore Medical Center - Moses campus (Site 206-003), 111 E. 210th Street
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19
2021. "ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04843761.
~118 spots leftby Apr 2025
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