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Can a rheumatoid arthritis drug save COVID-19 patients from lung failure?

NCT ID NCT04363853

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 tests whether the drug tocilizumab can help people with severe or critical COVID-19 who have serious lung problems (ARDS). About 200 adults will receive one or two doses and be followed for 30 days. The goal is to see if the drug improves survival and recovery. There is no placebo group because of the high risk of death.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2020

Expected to finish

Dec 2027

An estimate. End dates often move.

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 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Patients 18 years or older * Diagnosis of SARS-CoV-2 infection by RT-PCR * Diagnosis of serious or critical illness, without mechanical ventilation or with less than 24 hours of mechanical ventilation. * Severe: dyspnea, increase in respiratory rate ≥ 30 breaths / min, oxygen saturation \<90% or PaO2 \<60 mmHg or increase in supplemental oxygen requirement more than 3% from baseline, PaO2 / FiO2 \<300 mmHg, and / or pulmonary infiltrates by image\> 50% within 24 to 48 hours of symptom onset. * Critical: respiratory failure (alteration in gas exchange with PaO2 \<60 mmHg with or without elevation of PaCO2\> 33 mmHg), septic shock (hypotension secondary to sepsis with a requirement for vasopressors to maintain a mean arterial pressure\> 65 mmHg and lactate\> 2 mmol / l). * Signature of informed consent by the patient, family member or legal representative * Negative pregnancy test for women of childbearing age. * Male patients who agree to use barrier methods when having sexual intercourse in the following 80 days after receiving tocilizumab * Patients receiving immunomodulatory treatment (cancer, transplant recipients or other diseases) that may temporarily suspend the drug. Exclusion Criteria: * Pregnant or lactating women. * Patients who by indication of their treating doctor cannot suspend previous immunomodulatory treatment. * Known allergic reactions to Tocilizumab or any excipients. * Patients receiving systemic steroids at a dose greater than 1 mg / Kg of weight per day in prednisone equivalents * Patients with SOFA score\> 15 points that predicts 90% mortality on admission * The decision of the attending physician not to include the patient due to the presence of any condition that does not allow the administration of the drug to be safe. * Diverticulitis or intestinal perforation * Patients with any of the following active infections: viral hepatitis, tuberculosis, HIV infection, bacterial and/or fungal and/or viral infections (other than SARS-CoV-2 infection) suspected or diagnosed using compatible microbiological isolation. * Alanine aminotransferase/aspartate aminotransferase values\> 5 times the upper limit of normal * Neutrophil values \<1000/ml, * Platelet values \<50,000/ml.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • National Cancer Institute of Mexico

    Mexico City, Mexico City, 14080, Mexico

More trials for these conditions

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