Trial · NCT05187793
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical recovery rate at day 7 | Up to day 7 | Clinical recovery defined as score of 3 or less on a 10-point ordinal scale of clinical improvement. (From 0 "Healthy - no clinical manifestations, no viral RNA detected" to 10 "Death".) 7 days are counted from the day of the first administration / intake of study therapy / comparison therapy, depending on study group. Criteria for transition from category "4" to category "3" (criteria for potential discharge): body temperature \< 37 °C; respiratory rate ≤ 20 per minute; SpO2 ≥ 95% without oxygen support, CRP \< 10 mg/l. If any emergency procedures should be prescribed and/or signs of progression on CT are detected, the patient cannot be discharged/transferred to category "3". (In the case of the "rescue" therapy use or the development of clinical deterioration (an increase in the score by 1 point or more) during the follow-up period in a previously recovered patient, the patient is not considered as a "responder", i.e., who has reached the primary endpoint.) |
| Secondary | Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 28, depending on study group | Up to day 28 | Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 28, depending on study group |
| Secondary | CRP normalization rate | Up to Day 28 | Normalization is defined as CRP blood level within normal range (\< 10 mg/l), assessed on days 5, 10, 14, 28, depending on study group. |
| Secondary | Ferritin normalization rate | Up to Day 28 | Normalization is defined as ferritin blood level within normal range, assessed on days 5, 10, 14, 28, depending on study group. |
| Secondary | D-dimer normalization rate | Up to Day 28 | Normalization is defined as D-dimer blood level within normal range, assessed on days 5, 10, 14, 28, depending on study group. |
| Secondary | Mean CRP levels | Up to Day 28 | Mean CRP levels assessed on days 5, 10, 14, 28, depending on study group |
| Secondary | Mean ferritin levels | Up to Day 28 | Mean ferritin levels assessed on days 5, 10, 14, 28, depending on study group |
| Secondary | Mean D-dimer levels | Up to Day 28 | Mean D-dimer levels assessed on days 5, 10, 14, 28, depending on study group |
| Secondary | Rate of prescribing other anti-inflammatory therapy regimens (rescue therapy), depending on study group | Up to day 28 | Rate of prescribing other anti-inflammatory therapy regimens (rescue therapy), depending on study group |
| Other | Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 7, depending on study group | Up to day 7 | Rate of clinical deterioration by at least 1 point from the baseline ordinal score at day 7, depending on study group |
| Other | Clinical recovery rate at day 14 | Up to day 14 | Clinical recovery defined as score of 3 or less on a 10-point ordinal scale of clinical improvement, 14 days are counted from the day of the first administration / intake of study / comparison therapy by treatment group |
| Other | Cumulative incidence of transfer to intensive care unit (ICU), transfer to mechanical ventilation, development of ARDS and / or death, at day 28 | Uo to day 28 | Cumulative incidence of transfer to ICU, transfer to mechanical ventilation, development of ARDS and / or death, at day 28 |
| Other | Incidence of progression on chest CT at day 28 | Up to day 28 | Incidence of progression on chest CT at day 28, depending on study group |
| Other | Rate of transfer to ICU at day 28 | Up to day 28 | Rate of transfer to ICU at day 28, depending on study group |
| Other | Rate of transfer to mechanical ventilation at day 28 | Up to day 28 | Rate of transfer to mechanical ventilation at day 28, depending on study group |
| Other | Incidence of ARDS at day 28 | Up to day 28 | Incidence of ARDS at day 28, depending on study group |
| Other | Incidence of death from any cause at day 28 | Up to day 28 | Incidence of death from any cause at day 28, depending on study group |
| Other | Incidence of symptoms of a secondary bacterial infection | Up to day 28 | * leukocytosis \> 12x10\^9 / l (in the absence of previous use of glucocorticosteroids), * and / or shift to stab \> 10 %, * and / or purulent sputum or other clinical manifestations of purulent inflammation, * and / or an increase in procalcitonin\> 0.5 ng / ml depending on study group |
| Other | Time to improvement in clinical status by at least 1 point | from the moment of drug administration to improvement, up to 28 days | Time to improvement in clinical status by at least 1 point (from the moment of drug administration) (median, in days), depending on study group |
| Other | Incidence of improvement in clinical status by at least 1 point on days 3, 5, 7, 10, 14, 21, 28, depending on study group | Up to day 28 | Incidence of improvement in clinical status by at least 1 point on days 3, 5, 7, 10, 14, 21, 28, depending on study group |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05187793/registered