Trial · NCT05593770

International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response

NCT05593770, Phase 2, Phase 3, Terminated, NEAT ID Foundation; results first posted 2024-11-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response. Trials, record NCT05593770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05593770

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response
NCT number: NCT05593770
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 28 participants, actual
Lead sponsor: NEAT ID Foundation
Conditions: COVID-19, SARS-CoV2 Infection, Coronavirus Infection
Interventions: Fostamatinib, Placebo
First posted: 2022-10-25
Last updated: 2025-05-02
Results first posted: 2024-11-05
Limitations and caveats: Early termination due to DSMB findings of extremely low likelihood of the intervention having a beneficial effect on the primary outcome led to a small number of participants enrolled by international sites and analysis being performed with data from all participants (International and US sites) in the fostamatinib arm of the ACTIV-4 Host Tissue study. Results for all participants in the fostamatinib arm of the ACTIV-4 Host Tissue study are recorded in Clinicaltrials.gov record NCT04924660.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Oxygen Free Days Through Day 28	Day 1 to Day 28	This is defined as days alive and without supplemental oxygen use during the first 28 days following randomization. Patients who die on or before day 28 are assigned -1 oxygen free days. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Secondary	In-hospital Mortality	Day 1 to hospital discharge or Day 90 whichever comes first	Number of patients who die during hospitalization
Secondary	Alive and Oxygen Free at Day 14	Day 1 to Day 14	Number of patients oxygen free at day 14. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).
Secondary	Alive and Oxygen Free at Day 28	Day 1 to Day 28	Number of patients oxygen free at day 28. Patients will be considered to be receiving supplemental oxygen therapy when they are receiving any of the following: supplemental oxygen by nasal cannula, supplemental oxygen by face mask, high flow nasal cannula (HFNC), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO)
Secondary	Alive and Free of New Invasive Mechanical Ventilation at Day 28	Day 1 to Day 28	Number of patients alive free of new invasive mechanical ventilation at day 28
Secondary	28-day Mortality	Day 28	Number of patients who have died at Day 28
Secondary	60-day Mortality	Day 60	Number of patients who have died at Day 60
Secondary	90-day Mortality	Day 90	Number of participants mortality at Day 90
Secondary	Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14	Day 14	Number of participants who fell within the ordinal scale per the below criteria. A higher score indicates a worse outcome. 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead
Secondary	Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28	Day 28	The number of participants who fell within the ordinal scale per the below criteria. A higher score means a worse outcome 1. Ambulatory - Not hospitalized and no limitation of activities 2. Ambulatory - Not hospitalized with limitation of activities or home oxygen use 3. Hospitalized Mild Disease - Hospitalized, no oxygen therapy 4. Hospitalized Mild Disease - Hospitalized, oxygen by mask or nasal prongs 5. Hospitalized Severe Disease - Non-invasive ventilation or high-flow nasal cannula 6. Hospitalized Severe Disease -Invasive mechanical ventilation 7. Hospitalized Severe Disease - Invasive mechanical ventilation plus additional organ support with- vasopressors, RRT, or ECMO 8. Dead

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Oxygen Free Days Through Day 28	Day 1 to Day 28	The number of participants enrolled by international sites was insufficient for analysis due to the early termination of the trial. This analysis was performed on all participants enrolled to the fostamatinib arm of the ACTIV-4 Host Tissue platform (United states + International sites).The global fostamatinib arm of the ACTIV 4 study enrolled 400 participants, of which 28 were included from international sites and the results are reported in a separate Clinicaltrials.gov record, ref NCT04924660	days	MEAN
SECONDARY	In-hospital Mortality	Day 1 to hospital discharge or Day 90 whichever comes first	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Alive and Oxygen Free at Day 14	Day 1 to Day 14	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Alive and Oxygen Free at Day 28	Day 1 to Day 28	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Alive and Free of New Invasive Mechanical Ventilation at Day 28	Day 1 to Day 28	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	28-day Mortality	Day 28	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	60-day Mortality	Day 60	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	90-day Mortality	Day 90	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Status Assessed Using World Health Organization (WHO) 8-point Ordinal Scale at Day 14	Day 14	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinical Status Assessed Using WHO 8-point Ordinal Scale at Day 28	Day 28	Participants who lacked outcome data were not included in the analysis. Ineligible participants or those who didn't receive the treatment were excluded.	Participants	COUNT_OF_PARTICIPANTS

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group85

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Oxygen Free Days Through Day 28	Fostamatinib	13.4	Standard Deviation 12.4	days
Oxygen Free Days Through Day 28	Placebo	14.2	Standard Deviation 12.1	days
In-hospital Mortality	Fostamatinib	1		Participants
In-hospital Mortality	Placebo	1		Participants
Alive and Oxygen Free at Day 14	Fostamatinib	10		Participants
Alive and Oxygen Free at Day 14	Placebo	8		Participants
Alive and Oxygen Free at Day 28	Fostamatinib	11		Participants
Alive and Oxygen Free at Day 28	Placebo	9		Participants
Alive and Free of New Invasive Mechanical Ventilation at Day 28	Fostamatinib	12		Participants
Alive and Free of New Invasive Mechanical Ventilation at Day 28	Placebo	11		Participants

1 to 10 of 85Source ClinicalTrials.gov

See all 85 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Fostamatinib	14
Overall Study	STARTED	Placebo	14
Overall Study	COMPLETED	Fostamatinib	12
Overall Study	COMPLETED	Placebo	9
Overall Study	NOT COMPLETED	Fostamatinib	2
Overall Study	NOT COMPLETED	Placebo	5

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Constipation	Gastrointestinal disorders	Fostamatinib	0	14	0
other	Constipation	Gastrointestinal disorders	Placebo	1	14	1
other	Abdominal pain upper	Gastrointestinal disorders	Fostamatinib	1	14	1
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	0	14	0
other	Diarrhoea	Gastrointestinal disorders	Fostamatinib	0	14	0
other	Diarrhoea	Gastrointestinal disorders	Placebo	1	14	1
other	Vomiting	Gastrointestinal disorders	Fostamatinib	1	14	1
other	Vomiting	Gastrointestinal disorders	Placebo	0	14	0
other	Discomfort	General disorders	Fostamatinib	0	14	0
other	Discomfort	General disorders	Placebo	1	14	1

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fostamatinib	1	14
Total, all-cause mortality	Placebo	3	14
Total, other adverse events	Fostamatinib	8	14
Total, other adverse events	Placebo	4	14
Total, serious adverse events	Fostamatinib	8	14
Total, serious adverse events	Placebo	5	14

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons9

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fostamatinib vs Placebo: 28-day Mortality	Trial comparisons
Fostamatinib vs Placebo: Alive and Free of New Invasive Mechanical Ventilation at Day 28	Trial comparisons
Fostamatinib vs Placebo: Alive and Oxygen Free at Day 14	Trial comparisons
Fostamatinib vs Placebo: 90-day Mortality	Trial comparisons
Fostamatinib vs Placebo: Alive and Oxygen Free at Day 28	Trial comparisons
Fostamatinib vs Placebo: 60-day Mortality	Trial comparisons
Fostamatinib vs Placebo: deaths from any cause	Trial comparisons
Fostamatinib vs Placebo: In-hospital Mortality	Trial comparisons
Fostamatinib vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT05593770

GET https://conductscience.org/api/trials/v1/NCT05593770/results?page=2

API reference For AI assistants