Covid19Phase 3NCT04469114
Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia
A Phase 3 study testing Tofacitinib 10 mg in people with Covid19, run by Hospital Israelita Albert Einstein at 17 sites in Brazil.
Trial summary
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVID-19. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Tofacitinib 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 289 participants
- Where
- 17 sitesBrazil
- Study dates
- 16 Sep 2020to 9 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participants older than 18 years
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) prior to Day 1.
- Evidence of pneumonia assessed by radiographic imaging (chest x-ray or chest CT scan).
- Hospitalized for less than 72 hours and receiving supportive care for COVID-19
Who cannot join
- Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization
- History of or known current thrombosis. Only if current thrombosis is suspected by the investigator, imaging testing is recommended (per local guidance) to exclude thrombosis.
- Have a personal or first-degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
- Severe hepatic impairment, defined as Child-Pugh class C.
Show all 16Show fewer
- Severe anemia (hemoglobin <8 g/dL).
- Absolute lymphocyte count <500 cells/mm;
- Absolute neutrophil count <1000 cells/mm.
- Known allergy to tofacitinib.
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Suspected or known active systemic bacterial, fungal, or viral infections (with the exception of COVID-19) including but not limited to: active herpes zoster infection; known active tuberculosis or history of inadequately treated tuberculosis; known B hepatitis, C hepatitis, or HIV.
- Have received any of these within 4 weeks prior to the first dose of study intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra) within the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the past 28 days or 5 half-lives, whichever is longer.
- Have received estrogen-containing contraception or treatment with herbal supplements within 48 hours prior to the first dose of study intervention.
- Have received treatment with corticosteroids equivalent to prednisone or methylprednisolone >20 mg/day for equal or more than 14 consecutive days prior to screening.
- Current participation in other trials.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Brazil17 sites
Centro de Pesquisa Clínica do Coração
Aracaju
Hospital Universitário São Francisco de Assis Na Providência de Deu
Bragança Paulista
Irmandade do Sr. Bom Jesus dos Passos da Santa Casa de Misericórdia de Bragança Paulista
Bragança Paulista
Hospital do Coração do Brasil
Brasília
Instituto de Pesquisa Clínica de Campinas
Campinas
Hospital Regional do Litoral Norte
Caraguatatuba
Unimed Fortaleza Sociedade Corporativa Médica LTD
Fortaleza
Hospital Regional Jorge Rossmann
Itanhaém
Hospital Bruno Born
Lajeado
Hospital São Vicente de Paulo
Passo Fundo
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
Hospital Regional de Registro
São José dos Campos
Hospital Regional de São José dos Campos
São José dos Campos
Beneficência Portuguesa
São Paulo
BP Mirante
São Paulo
Hospital Israelita Albert Einstein
São Paulo
Instituto do Coração
São Paulo
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.
Read the detailed description
COVID-19 is a viral disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that can cause severe pneumonia and ARDS. Respiratory viral load may peak within 5 days after onset, while symptoms are still mild. Many patients rapidly (within 1 to 2 weeks of infection) develop dyspnea and pneumonia and require hospitalization for respiratory support.
Preliminary clinical data from COVID-19 patients indicate that severe symptoms with SARS-CoV-2 infection are associated with an exaggerated immune response driven by interleukin (IL)-6 IL-10, tumor necrosis factor (TNF)α, and other cytokines. The ultimate result is progressive destruction of the alveolar epithelium leading to pneumonia and/or ARDS. Moreover, the exudative phase of ARDS is thought to be due to an influx of myeloid cells (neutrophils and macrophages) and elevations of inflammatory cytokines, with higher levels of both IL-6 and IL-8 levels being correlated with increased mortality. Therefore, immunomodulatory therapy may be beneficial in reducing the deleterious effects of lung inflammation and mitigating progressive lung injury.
Tofacitinib is an inhibitor of Janus kinase (JAKs) 1 and 3, with partial selectivity to JAK 2. Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and ARDS in patients with COVID-19.
The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.
Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR, who have agreed to participate, will be screened within 72h hours after admission to the hospital to determine eligibility.
Eligible participants will be randomized on Day 1 to the tofacitinib plus standard of care treatment group or the placebo plus standard of care treatment group in a 1:1 ratio, stratified by site. Participants will receive treatment for up to 14 days or until discharge from the hospital, whichever is earlier.
Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 14 and on Day 28.
- Conditions
- Covid19
- Being tested
- Tofacitinib 10 mg, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 10 mgDrug
Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge
PlaceboDrug
Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge
| Study group | Role | What they receive |
|---|---|---|
| Tofacitinib | Experimental | Tofacitinib 10mg twice daily for 14 days or until hospital discharge Receives: Drug: Tofacitinib 10 mg |
| Placebo | Placebo comparator | Placebo twice daily for 14 days or until hospital discharge Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or respiratory failure until Day 28
1, 2 or 3 on the 8-point National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity. The minimum value is 1 (worst outcome) and the maximum value is 8 (best outcome).
- Death.
- Hospitalized, on invasive mechanical ventilation or ECMO.
- Hospitalized, on non-invasive ventilation or high-flow oxygen devices.
- Hospitalized, requiring supplemental oxygen.
- Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise).
- Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
- Not hospitalized, limitation on activities and/or requiring home oxygen.
- Not hospitalized, with no limitations on activities.
Measured: 28 days
Secondary outcomes (11)
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14
NIAID ordinal scale of disease severity
Measured: 14 days
Status of alive and not on mechanical ventilation or ECMO at Day 14 and 28 NIAID ordinal scale of disease severity at Day 14
Categories 3 to 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 and Day 28
Measured: 14 and 28 days
Status of requiring supplemental oxygen at Day 28
Categories 1 to 4 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity
Measured: 28 days
Status of being alive and not hospitalized at Day 14 and 28
Categories 7 and 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity
Measured: 14 and 28 days
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 NIAID ordinal scale of disease severity at Day 28
NIAID ordinal scale of disease severity
Measured: 28 days
Number of patients with cure
Number of patients with resolution of fever, cough, and need for ventilatory or oxygen support.
Measured: 28 days
Number of patients at the ICU or on ventilatory support at Day 28
Number of patients at the ICU or on ventilatory support
Measured: 28 days
Number of days free from mechanical ventilation at 28 days
Number of days free from mechanical ventilation
Measured: 28 days
Number of days in hospital
Number of days in hospital
Measured: 28 days
Number of days in ICU
Number of days in ICU
Measured: 28 days
Death or respiratory failure at Day 28
Categories 1 to 3 in the National Institute of Allergy and Infectious Diseases (NIAID)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start16 Sep 2020
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 289 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469114
- Sponsor's protocol ID
- 34810620.0.1001.0071
- Status last verified
- Jul 2020
- First submitted
- 10 Jul 2020
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guimaraes PO, Damiani LP, Tavares CAM, Halpern ASR, Deuring JJ, Rizzo LV, Berwanger O. Laboratory profiles of patients hospitalized with COVID-19 pneumonia treated with tofacitinib or placebo: a post hoc analysis from the STOP-COVID trial. Einstein (Sao Paulo). 2024 Nov 4;22:eAO0821. doi: 10.31744/einstein_journal/2024AO0821. eCollection 2024.
PubMed 39504090Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.
PubMed 35695334Guimaraes PO, Quirk D, Furtado RH, Maia LN, Saraiva JF, Antunes MO, Kalil Filho R, Junior VM, Soeiro AM, Tognon AP, Veiga VC, Martins PA, Moia DDF, Sampaio BS, Assis SRL, Soares RVP, Piano LPA, Castilho K, Momesso RGRAP, Monfardini F, Guimaraes HP, Ponce de Leon D, Dulcine M, Pinheiro MRT, Gunay LM, Deuring JJ, Rizzo LV, Koncz T, Berwanger O; STOP-COVID Trial Investigators. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jul 29;385(5):406-415. doi: 10.1056/NEJMoa2101643. Epub 2021 Jun 16.
PubMed 34133856
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia
- ClinicalTrials.gov ID
- NCT04469114
- Acronym / sponsor ID
- 34810620.0.1001.0071
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 289 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in patients with COVID-19. The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.
Detailed description
COVID-19 is a viral disease caused by a novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), that can cause severe pneumonia and ARDS. Respiratory viral load may peak within 5 days after onset, while symptoms are still mild. Many patients rapidly (within 1 to 2 weeks of infection) develop dyspnea and pneumonia and require hospitalization for respiratory support.
Preliminary clinical data from COVID-19 patients indicate that severe symptoms with SARS-CoV-2 infection are associated with an exaggerated immune response driven by interleukin (IL)-6 IL-10, tumor necrosis factor (TNF)α, and other cytokines. The ultimate result is progressive destruction of the alveolar epithelium leading to pneumonia and/or ARDS. Moreover, the exudative phase of ARDS is thought to be due to an influx of myeloid cells (neutrophils and macrophages) and elevations of inflammatory cytokines, with higher levels of both IL-6 and IL-8 levels being correlated with increased mortality. Therefore, immunomodulatory therapy may be beneficial in reducing the deleterious effects of lung inflammation and mitigating progressive lung injury.
Tofacitinib is an inhibitor of Janus kinase (JAKs) 1 and 3, with partial selectivity to JAK 2. Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to progression to more severe lung disease and ARDS in patients with COVID-19.
The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized participants with COVID-19 pneumonia.
Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR, who have agreed to participate, will be screened within 72h hours after admission to the hospital to determine eligibility.
Eligible participants will be randomized on Day 1 to the tofacitinib plus standard of care treatment group or the placebo plus standard of care treatment group in a 1:1 ratio, stratified by site. Participants will receive treatment for up to 14 days or until discharge from the hospital, whichever is earlier.
Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety, and laboratory parameters. Follow-up visits will occur on Day 14 and on Day 28.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tofacitinib | Experimental | Drug: Tofacitinib 10 mgTofacitinib 10mg twice daily for 14 days or until hospital discharge |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice daily for 14 days or until hospital discharge |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female participants older than 18 years
- Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) prior to Day 1.
- Evidence of pneumonia assessed by radiographic imaging (chest x-ray or chest CT scan).
- Hospitalized for less than 72 hours and receiving supportive care for COVID-19
Key exclusion criteria (16 listed)
- Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) on Day 1 at the time of randomization
- History of or known current thrombosis. Only if current thrombosis is suspected by the investigator, imaging testing is recommended (per local guidance) to exclude thrombosis.
- Have a personal or first-degree family history of blood clotting disorders.
- Participants who are immunocompromised, with known immunodeficiencies, or taking potent immunosuppressive agents (eg, azathioprine, cyclosporine).
- Participants with any current malignancy or lymphoproliferative disorders that requires active treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tofacitinib 10 mgTofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge | Drug | Tofacitinib |
| PlaceboTofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge | Drug | Placebo |
Primary outcome
Death or respiratory failure until Day 28
Time frame: 28 days
1, 2 or 3 on the 8-point National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity. The minimum value is 1 (worst outcome) and the maximum value is 8 (best outcome). 1. Death. 2. Hospitalized, on invasive mechanical ventilation or ECMO. 3. Hospitalized, on non-invasive ventilation or high-flow oxygen devices. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise). 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7. Not hospitalized, limitation on activities and/or requiring home oxygen. 8. Not hospitalized, with no limitations on activities.
11 secondary outcomes
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14
Time frame: 14 days
Status of alive and not on mechanical ventilation or ECMO at Day 14 and 28 NIAID ordinal scale of disease severity at Day 14
Time frame: 14 and 28 days
Status of requiring supplemental oxygen at Day 28
Time frame: 28 days
Status of being alive and not hospitalized at Day 14 and 28
Time frame: 14 and 28 days
National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 NIAID ordinal scale of disease severity at Day 28
Time frame: 28 days
Number of patients with cure
Time frame: 28 days
Number of patients at the ICU or on ventilatory support at Day 28
Time frame: 28 days
Number of days free from mechanical ventilation at 28 days
Time frame: 28 days
Number of days in hospital
Time frame: 28 days
Number of days in ICU
Time frame: 28 days
Death or respiratory failure at Day 28
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 39504090Guimaraes PO, Damiani LP, Tavares CAM, Halpern ASR, Deuring JJ, Rizzo LV, Berwanger O. Laboratory profiles of patients hospitalized with COVID-19 pneumonia treated with tofacitinib or placebo: a post hoc analysis from the STOP-COVID trial. Einstein (Sao Paulo). 2024 Nov 4;22:eAO0821. doi: 10.31744/einstein_journal/2024AO0821. eCollection 2024.
- Derived from this study: PubMed 35695334Kramer A, Prinz C, Fichtner F, Fischer AL, Thieme V, Grundeis F, Spagl M, Seeber C, Piechotta V, Metzendorf MI, Golinski M, Moerer O, Stephani C, Mikolajewska A, Kluge S, Stegemann M, Laudi S, Skoetz N. Janus kinase inhibitors for the treatment of COVID-19. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD015209. doi: 10.1002/14651858.CD015209.
- Derived from this study: PubMed 34133856Guimaraes PO, Quirk D, Furtado RH, Maia LN, Saraiva JF, Antunes MO, Kalil Filho R, Junior VM, Soeiro AM, Tognon AP, Veiga VC, Martins PA, Moia DDF, Sampaio BS, Assis SRL, Soares RVP, Piano LPA, Castilho K, Momesso RGRAP, Monfardini F, Guimaraes HP, Ponce de Leon D, Dulcine M, Pinheiro MRT, Gunay LM, Deuring JJ, Rizzo LV, Koncz T, Berwanger O; STOP-COVID Trial Investigators. Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia. N Engl J Med. 2021 Jul 29;385(5):406-415. doi: 10.1056/NEJMoa2101643. Epub 2021 Jun 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tofacitinib 10 mg in people with Covid19, run by Hospital Israelita Albert Einstein at 17 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death or respiratory failure until Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04469114, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.