Can a rheumatoid arthritis drug save COVID-19 patients from lung failure?
NCT ID NCT04363853
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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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.
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