Trial · NCT04334460
Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects
NCT04334460, Phase 2, Completed, Blade Therapeutics; results first posted 2022-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects. Trials, record NCT04334460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04334460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Antiviral Activity of BLD-2660 in COVID-19 Hospitalized Subjects
- NCT number
- NCT04334460
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Blade Therapeutics
- Conditions
- Sars-CoV-2, Covid19
- Interventions
- BLD-2660
- First posted
- 2020-04-06
- Last updated
- 2022-04-06
- Results first posted
- 2022-04-06
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Recovery | Course of study; 28 days | To evaluate time to recovery as defined by no longer requiring oxygen support or hospital discharge, whichever occurs first. |
| Primary | Change in Oxygenation | 10 days | To evaluate change in oxygenation in hospitalized adults with COVID-19 treated with BLD-2660. Measured by change from baseline to Day 10 or hospital discharge, if sooner, in the ratio of peripheral hemoglobin oxygen saturation to fraction of inspired oxygen (SpO2/FiO2) |
| Secondary | Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Course of study; 28 days | To evaluate the safety and tolerability of BLD-2660 in the same population. Measured by incidence of TEAEs and serious adverse events (SAEs) |
| Other | Time to Discharge Readiness | Course of study; 28 days | Measured by time to discharge readiness |
| Other | Proportion of Subjects Discharged During Study | Course of study; 28 days | Measured by proportion of subjects ready to be discharged from the hospital during the 28-day study period following enrollment. |
| Other | Time to Resolution of Fever | Course of study; 28 days | Measured by time to resolution of fever below entry criteria for 24 hours in subjects with fever at baseline |
| Other | Duration of Remdesivir Use | Course of study; 28 days | Measured by duration (in days) of remdesivir use in subjects starting remdesivir within 24 hours of first dose of BLD-2660 |
| Other | Change in Clinical Status | Course of study; 28 days | Measured by change from baseline to Days 10, 14, 21 and 28 in clinical status outcome using a 6-point ordinal scale |
| Other | Percentage of Subjects in Each Category of the 6-point Ordinal Scale | Course of study; 28 days | Measured by percentage of subjects reporting each 6-point ordinal scale of the clinical status outcome assessment. |
| Other | Change in IL-6 | Course of study; 28 days | Measured by change from baseline to Days 10, 14, 21 and 28 in IL-6 in ng/mL measured by analytical assay |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Recovery | Course of study; 28 days | FAS Set | days | MEDIAN |
| PRIMARY | Change in Oxygenation | 10 days | FAS Set | Ratio | LEAST_SQUARES_MEAN |
| SECONDARY | Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Course of study; 28 days | Safety Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Time to Discharge Readiness | Course of study; 28 days | FAS Set | Days | MEDIAN |
| OTHER_PRE_SPECIFIED | Proportion of Subjects Discharged During Study | Course of study; 28 days | |||
| OTHER_PRE_SPECIFIED | Time to Resolution of Fever | Course of study; 28 days | |||
| OTHER_PRE_SPECIFIED | Duration of Remdesivir Use | Course of study; 28 days | |||
| OTHER_PRE_SPECIFIED | Change in Clinical Status | Course of study; 28 days | FAS Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Subjects in Each Category of the 6-point Ordinal Scale | Course of study; 28 days | FAS Set | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change in IL-6 | Course of study; 28 days | FAS Set. Only participants in the FAS with data at the respective time point are summarized. | ng/L | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group100
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Recovery | Active Group | 5 | 95% Confidence Interval 3.00 to 6.00 | days | |
| Time to Recovery | Placebo Group | 4.5 | 95% Confidence Interval 4.00 to 6.00 | days | |
| Change in Oxygenation | Active Group | 33.8 | Standard Error 17.10 | Ratio | |
| Change in Oxygenation | Placebo Group | 66.8 | Standard Error 25.58 | Ratio | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Active Group | Number of Subjects with >=1 TEAE | 42 | Participants | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Placebo Group | Number of Subjects with >=1 TEAE | 23 | Participants | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Active Group | Number of Subjects with >=1 Treatment-Related TEAE | 10 | Participants | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Placebo Group | Number of Subjects with >=1 Treatment-Related TEAE | 6 | Participants | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Active Group | Number of Subjects with >=1 TEAE with Grade 3 or higher | 12 | Participants | |
| Safety & Tolerability: Incidence of TEAEs and Serious Adverse Events (SAEs) | Placebo Group | Number of Subjects with >=1 TEAE with Grade 3 or higher | 9 | Participants |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Full Enrollment | STARTED | Active Group | 81 | |
| Full Enrollment | STARTED | Placebo Group | 39 | |
| Full Enrollment | COMPLETED | Active Group | 81 | |
| Full Enrollment | COMPLETED | Placebo Group | 39 | |
| Full Enrollment | NOT COMPLETED | Active Group | 0 | |
| Full Enrollment | NOT COMPLETED | Placebo Group | 0 | |
| Full Analysis Set (FAS) | STARTED | Active Group | 81 | |
| Full Analysis Set (FAS) | STARTED | Placebo Group | 39 | |
| Full Analysis Set (FAS) | COMPLETED | Active Group | 77 | |
| Full Analysis Set (FAS) | COMPLETED | Placebo Group | 38 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events188
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 | Anaemia | Blood and lymphatic system disorders | Active Group | 1 | 77 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Group | 0 | 38 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Active Group | 1 | 77 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Placebo Group | 0 | 38 | |
| other | Leukopenia | Blood and lymphatic system disorders | Active Group | 1 | 77 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo Group | 0 | 38 | |
| other | Angina pectoris | Cardiac disorders | Active Group | 1 | 77 | |
| other | Angina pectoris | Cardiac disorders | Placebo Group | 0 | 38 | |
| other | Cardiomegaly | Cardiac disorders | Active Group | 0 | 77 | |
| other | Cardiomegaly | Cardiac disorders | Placebo Group | 1 | 38 |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active Group | 2 | 77 |
| Total, all-cause mortality | Placebo Group | 2 | 38 |
| Total, other adverse events | Active Group | 42 | 77 |
| Total, other adverse events | Placebo Group | 23 | 38 |
| Total, serious adverse events | Active Group | 9 | 77 |
| Total, serious adverse events | Placebo Group | 9 | 38 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Active Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Active Group vs Placebo Group: 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.
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/NCT04334460
GET https://conductscience.org/api/trials/v1/NCT04334460/results?page=2