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COVID-19 drug study pulled before it even started

NCT ID NCT07196306

Disease control Sponsor: BayCare Health System Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if the drug sarilumab could help hospitalized COVID-19 patients with severe breathing distress. It planned to compare one or two doses of sarilumab against a placebo. However, the study was withdrawn before enrolling any participants, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Started

May 2020

Finished

Oct 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Confirmed COVID-19 via centralized RT-PCR testing for SARS-CoV2 infection performed at BayCare Health System Laboratory or associated and accredited laboratory. 2. Subjects must be hospitalized. 3. Document fever of 100.4 F or more during hospitalization and prior to enrollment. 4. Evidence of abnormal chest imaging chest x-ray or CT. 5. Moderate to severe respiratory distress requiring oxygen supplementation as defined by criteria listed below. "Oxygen saturation (Sao2) of 92% or less on room air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 200 mm Hg, on ventilator settings that include PEEP ≥5 cm H2O". 6. Subjects may have active co-infection with other respiratory pathogens. 7. Males and non-pregnant females at least 18 years of age. Exclusion Criteria: 1. The subject or Legally Authorized Representative is unable to provide consent in person or by phone. 2. The subject is participating in any other clinical trial for treatment of COVID 19 or any other treatment related clinical trial for a concurrent disease. No plans for additional COVID trials. 3. The subject does not meet criteria for moderate to severe respiratory distress. 4. The presence of any of the following lab abnormalities. ANC \<2000/mm3, Platelet count \<50,000/mm3, ALT/AST \>6x ULN 5. Prior utilization of any IL-6 inhibitors or receptor antagonists at any time in patient's life, JAK inhibitors, DMARDS(Except Hydroxychloroquine), long term, chronic steroid use (more than 6 months) or mTOR inhibitors. 6. The subject has history of organ or bone marrow transplant. 7. History of active or incompletely treated Tuberculosis (TB).

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Orthocoronavirinae infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corona virus infection COVID COVID -19

Contacts and locations

Locations

  • Morton Plant Hospital

    Clearwater, Florida, 33756, United States

  • St. Anthony's Hospital

    St. Petersburg, Florida, 33705, United States

  • St. Joseph's Hospital

    Tampa, Florida, 33614, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.