NCT04640168 is a Phase 3 clinical trial of Baricitinib in COVID-19, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT04640168?

NCT04640168 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT04640168?

Interventions in NCT04640168: Baricitinib, Dexamethasone, Placebo, Remdesivir.

Is NCT04640168 still recruiting?

NCT04640168 is currently completed. Last updated 28 June 2022.

Are results published for NCT04640168?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-06-28 · How we verify

NCT04640168

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Adaptive COVID-19 Treatment Trial 4 (ACTT-4)

Completed Phase 3 Results posted Last updated 28 June 2022

What this trial tests

Phase 3 trial testing Baricitinib in COVID-19 in 1,010 participants. Completed in 18 June 2021.

Timeline

2 December 2020

Primary endpoint
18 May 2021

18 June 2021

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,010
Start date	2 December 2020
Primary completion	18 May 2021
Estimated completion	18 June 2021
Sites	72 locations across Japan, South Korea, Mexico, Singapore, United States

Drugs / interventions tested

Baricitinib (baricitinib) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Placebo
Remdesivir (remdesivir) — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 99, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

The Proportion of Participants Not Meeting Criteria for One of the Following Two Ordinal Scale Categories at Any Time: 8) Death; 7) Hospitalized, on Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) Primary · Day 1 through Day 29

Mechanical ventilation-free survival was assessed through Day 29, defined as the proportion of participants who had not died nor were hospitalized on invasive mechanical ventilation or ECMO as of Day 29. Results are reported as Kaplan Meier estimates.

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.87	0.84 – 0.90
Remdesivir Plus Dexamethasone	0.88	0.84 – 0.90

Change From Baseline in Alanine Aminotransferase (ALT) Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate ALT was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	1.1	-0.9 – 3.1
Remdesivir Plus Dexamethasone	4.3	1.2 – 7.4

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	6.0	0.8 – 11.2
Remdesivir Plus Dexamethasone	15.9	11.6 – 20.1

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	4.7	-5.9 – 15.3
Remdesivir Plus Dexamethasone	16.1	2.6 – 29.7

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	5.6	-2.0 – 13.2
Remdesivir Plus Dexamethasone	15.5	4.1 – 26.9

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	7.1	-1.1 – 15.2
Remdesivir Plus Dexamethasone	8.2	-3.3 – 19.8

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-3.8	-16.3 – 1.0
Remdesivir Plus Dexamethasone	1.1	-26.3 – 18.5

Change From Baseline in Aspartate Aminotransferase (AST) Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate AST was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	-5.9	-8.1 – -3.6
Remdesivir Plus Dexamethasone	-7.2	-12.8 – -1.7

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	-4.0	-11.9 – 3.9
Remdesivir Plus Dexamethasone	-8.5	-13.1 – -4.0

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	-10.8	-19.8 – -1.8
Remdesivir Plus Dexamethasone	-12.0	-27.6 – 3.6

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	-12.1	-19.4 – -4.9
Remdesivir Plus Dexamethasone	-16.4	-23.0 – -9.8

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-13.4	-19.9 – -6.8
Remdesivir Plus Dexamethasone	-15.4	-20.8 – -10.0

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-18.6	-23.8 – -13.4
Remdesivir Plus Dexamethasone	9.9	-53.3 – 73.2

Change From Baseline in C-reactive Protein (CRP) Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate CRP was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	-41.1	-46.6 – -35.5
Remdesivir Plus Dexamethasone	-61.0	-66.9 – -55.2

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	-39.4	-46.0 – -32.8
Remdesivir Plus Dexamethasone	-73.6	-80.1 – -67.0

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	-53.0	-60.3 – -45.7
Remdesivir Plus Dexamethasone	-79.0	-86.1 – -72.0

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	-61.6	-69.2 – -54.1
Remdesivir Plus Dexamethasone	-81.6	-88.9 – -74.3

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-73.2	-80.8 – -65.7
Remdesivir Plus Dexamethasone	-81.1	-88.7 – -73.4

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-78.6	-86.2 – -70.9
Remdesivir Plus Dexamethasone	-84.1	-91.8 – -76.4

Change From Baseline in Creatinine Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate serum creatinine was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.207	-0.521 – 0.108
Remdesivir Plus Dexamethasone	-0.081	-0.102 – -0.059

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.287	-0.701 – 0.127
Remdesivir Plus Dexamethasone	-0.122	-0.147 – -0.097

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.434	-1.175 – 0.308
Remdesivir Plus Dexamethasone	-0.096	-0.132 – -0.060

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.007	-0.121 – 0.135
Remdesivir Plus Dexamethasone	-0.102	-0.165 – -0.039

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.011	-0.101 – 0.080
Remdesivir Plus Dexamethasone	-0.024	-0.086 – 0.039

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.064	-0.100 – -0.029
Remdesivir Plus Dexamethasone	-0.029	-0.090 – 0.031

Change From Baseline in D-dimer Concentration Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate d-dimer concentration was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.8	0.3 – 1.3
Remdesivir Plus Dexamethasone	0.2	-0.1 – 0.6

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.7	0.3 – 1.1
Remdesivir Plus Dexamethasone	0.7	0.2 – 1.2

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.7	0.2 – 1.2
Remdesivir Plus Dexamethasone	0.9	0.3 – 1.5

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.7	0.0 – 1.3
Remdesivir Plus Dexamethasone	0.5	0.0 – 0.9

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.1	-0.2 – 0.3
Remdesivir Plus Dexamethasone	0.3	-0.1 – 0.7

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.1	-0.2 – 0.3
Remdesivir Plus Dexamethasone	0.2	-0.2 – 0.6

Change From Baseline in Glucose Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate glucose was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	-46.9	-53.0 – -40.8
Remdesivir Plus Dexamethasone	3.8	-2.4 – 10.0

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	-43.2	-50.9 – -35.5
Remdesivir Plus Dexamethasone	-6.7	-14.9 – 1.5

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	-35.0	-45.5 – -24.4
Remdesivir Plus Dexamethasone	-9.6	-22.0 – 2.8

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	-28.1	-43.2 – -13.0
Remdesivir Plus Dexamethasone	-15.0	-30.6 – 0.6

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-26.0	-35.3 – -16.6
Remdesivir Plus Dexamethasone	-20.2	-31.3 – -9.1

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-28.9	-38.8 – -19.0
Remdesivir Plus Dexamethasone	-25.4	-36.1 – -14.8

Change From Baseline in Hemoglobin Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate hemoglobin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.51	-0.59 – -0.43
Remdesivir Plus Dexamethasone	-0.25	-0.35 – -0.15

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.64	-0.80 – -0.47
Remdesivir Plus Dexamethasone	-0.13	-0.25 – 0.00

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	-1.08	-1.28 – -0.88
Remdesivir Plus Dexamethasone	-0.15	-0.37 – 0.07

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	-1.44	-1.75 – -1.13
Remdesivir Plus Dexamethasone	-0.76	-1.03 – -0.48

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.97	-1.23 – -0.71
Remdesivir Plus Dexamethasone	-0.91	-1.13 – -0.69

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.51	-0.75 – -0.28
Remdesivir Plus Dexamethasone	-0.66	-0.93 – -0.39

Change From Baseline in Platelets Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate platelets was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	53.1	48.6 – 57.5
Remdesivir Plus Dexamethasone	70.4	65.6 – 75.1

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	107.4	98.8 – 116.0
Remdesivir Plus Dexamethasone	117.6	108.9 – 126.4

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	178.9	161.4 – 196.3
Remdesivir Plus Dexamethasone	140.4	125.7 – 155.1

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	193.9	166.5 – 221.3
Remdesivir Plus Dexamethasone	105.0	86.7 – 123.4

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	139.6	119.0 – 160.3
Remdesivir Plus Dexamethasone	45.3	29.4 – 61.1

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	35.3	22.8 – 47.8
Remdesivir Plus Dexamethasone	69.4	56.1 – 82.7

Change From Baseline in Prothrombin International Normalized Ratio (INR) Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate INR was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.06	0.04 – 0.09
Remdesivir Plus Dexamethasone	-0.01	-0.08 – 0.06

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.11	0.09 – 0.13
Remdesivir Plus Dexamethasone	-0.03	-0.13 – 0.07

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.11	0.08 – 0.14
Remdesivir Plus Dexamethasone	-0.08	-0.25 – 0.09

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.09	0.03 – 0.14
Remdesivir Plus Dexamethasone	-0.14	-0.42 – 0.14

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.00	-0.03 – 0.03
Remdesivir Plus Dexamethasone	-0.04	-0.08 – 0.00

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.06	-0.09 – -0.04
Remdesivir Plus Dexamethasone	-0.05	-0.08 – -0.03

Change From Baseline in Total Bilirubin Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate total bilirubin was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.00	-0.02 – 0.02
Remdesivir Plus Dexamethasone	-0.09	-0.11 – -0.07

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.06	0.03 – 0.08
Remdesivir Plus Dexamethasone	-0.03	-0.06 – 0.01

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.03	-0.01 – 0.06
Remdesivir Plus Dexamethasone	0.03	-0.01 – 0.07

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.04	-0.03 – 0.11
Remdesivir Plus Dexamethasone	0.05	-0.01 – 0.11

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.01	-0.06 – 0.04
Remdesivir Plus Dexamethasone	0.03	-0.02 – 0.08

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	-0.02	-0.05 – 0.02
Remdesivir Plus Dexamethasone	-0.05	-0.10 – -0.01

Change From Baseline in White Blood Cell Count (WBC) Secondary · Days 1, 3, 5, 8, 11, 15 and 29

Blood to evaluate WBC was collected at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29, with the Day 1 assessment serving as baseline. Participants who had been discharged had blood collected if infection control measures allowed for in-person visits after discharge.

Day 3

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.433	0.196 – 0.670
Remdesivir Plus Dexamethasone	1.292	1.054 – 1.529

Day 5

Group	Value	95% CI
Remdesivir Plus Baricitinib	1.358	1.006 – 1.709
Remdesivir Plus Dexamethasone	2.072	1.712 – 2.432

Day 8

Group	Value	95% CI
Remdesivir Plus Baricitinib	2.629	1.946 – 3.311
Remdesivir Plus Dexamethasone	4.048	3.415 – 4.681

Day 11

Group	Value	95% CI
Remdesivir Plus Baricitinib	4.153	3.098 – 5.209
Remdesivir Plus Dexamethasone	5.179	4.177 – 6.182

Day 15

Group	Value	95% CI
Remdesivir Plus Baricitinib	1.638	0.965 – 2.310
Remdesivir Plus Dexamethasone	2.386	1.697 – 3.074

Day 29

Group	Value	95% CI
Remdesivir Plus Baricitinib	0.688	0.103 – 1.273
Remdesivir Plus Dexamethasone	0.116	-0.468 – 0.699

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious and Grade 3 and 4 non-serious adverse events were collected for 29 days after the first dose. Laboratory values were systematically assessed at Days 1, 3, 5, 8, and 11 while participants were inpatient, and at Days 15 and 29. Treatment emergent and fatal AEs are reported.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Remdesivir Plus Baricitinib

Serious: 95/503 (19%)

Deaths: 28/516

Remdesivir Plus Dexamethasone

Serious: 94/482 (20%)

Deaths: 34/494

Serious adverse events (62 terms)

Reaction	System	Remdesivir Plus Baricitinib	Remdesivir Plus Dexamethas…
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory distress	Respiratory, thoracic and mediastinal disorders	—	—
Acute kidney injury	Renal and urinary disorders	—	—
Pneumonia	Infections and infestations	—	—
Multiple organ dysfunction syndrome	General disorders	—	—
Septic shock	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—
Pneumonia bacterial	Infections and infestations	—	—
Failure to thrive	Metabolism and nutrition disorders	—	—
Cerebrovascular accident	Nervous system disorders	—	—
Cardiac arrest	Cardiac disorders	—	—
Cardio-respiratory arrest	Cardiac disorders	—	—
Myocardial infarction	Cardiac disorders	—	—
Supraventricular tachycardia	Cardiac disorders	—	—
Glomerular filtration rate decreased	Investigations	—	—
Renal failure	Renal and urinary disorders	—	—
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	—	—
Hypotension	Vascular disorders	—	—
Shock	Vascular disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Hypercoagulation	Blood and lymphatic system disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Remdesivir Plus Baricitinib	Remdesivir Plus Dexamethas…
Lymphocyte count decreased	Investigations	—	—

Most-reported serious reactions: Respiratory failure, Acute respiratory failure, Pulmonary embolism, Respiratory distress, Acute kidney injury, Pneumonia, Multiple organ dysfunction syndrome, Septic shock.

Data from ClinicalTrials.gov NCT04640168 adverse events section.

Sponsor's own description

ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tofacitinib in Patients Hospitalized with Covid-19 Pneumonia.
Guimarães PO, Quirk D, Furtado RH, Maia LN, et al · · 2021 · cited 348× · PMID 34133856 · DOI 10.1056/nejmoa2101643
Cytokine Storm in COVID-19: Immunopathogenesis and Therapy.
Zanza C, Romenskaya T, Manetti AC, Franceschi F, et al · · 2022 · cited 211× · PMID 35208467 · DOI 10.3390/medicina58020144
An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
Systemic corticosteroids for the treatment of COVID-19.
Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2
The Drug Repurposing for COVID-19 Clinical Trials Provide Very Effective Therapeutic Combinations: Lessons Learned From Major Clinical Studies.
Chakraborty C, Sharma AR, Bhattacharya M, Agoramoorthy G, et al · · 2021 · cited 97× · PMID 34867318 · DOI 10.3389/fphar.2021.704205
Selectivity, efficacy and safety of JAKinibs: new evidence for a still evolving story.
Bonelli M, Kerschbaumer A, Kastrati K, Ghoreschi K, et al · · 2024 · cited 95× · PMID 37923366 · DOI 10.1136/ard-2023-223850
JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04640168 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 28 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04640168.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04640168

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (62 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Baricitinib

Other recruiting trials for COVID-19

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources