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| Column | Value |
|---|---|
| Trial registration number | NCT04843761 |
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Full text link
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : June 4, 2022, 2 p.m. Source : ClinicalTrials.gov |
not reported |
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Registration date
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-04-14 |
|
Recruitment status
Last imported at : Dec. 22, 2022, noon Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - signed informed consent. - requiring admission to hospital for acute medical care (not for purely public health or quarantine purposes). - current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation, or ecmo (extracorporeal membrane oxygenation) used to treat acute hypoxemic respiratory failure). - sars-cov-2 (covid-19) infection, documented by a nucleic acid test (nat) or equivalent testing with most recent rest within 14 days prior to randomization. - respiratory failure is believed to be due to sars-cov-2 pneumonia. |
|
Exclusion criteria
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- known allergy to investigational agent or vehicle. - more than 4 days since initiation of support for respiratory failure. - chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or neuromuscular disease (non-invasive ventilation used solely for sleep-disordered breathing is not an exclusion). - moribund patient (i.e. not expected to survive 24 hours). - active use of "comfort care" or other hospice-equivalent standard of care. - expected inability to participate in study procedures. - in the opinion of the investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol-specified assessments. - previous enrollment in tesico agent-specific exclusion criteria - prior receipt of any dose of remdesivir during present illness (remdesivir agent). - gfr (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir agent). - alt (alanine aminotransferase) or ast (aspartate aminotransferase) > 10 times upper limit of normal (remdesivir agent). - unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days after completion of remdesivir vs. placebo (remdesivir agent). - refractory hypotension (aviptadil agent). - severe diarrhea (aviptadil agent). - current c. difficile infection (aviptadil agent). - pregnancy or current breast-feeding (aviptadil agent). - end-stage liver disease (aviptadil agent). |
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Number of arms
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Inclusion age min
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 22, 2022, noon Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Critical disease at enrollment |
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Severity scale
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
8: Critical disease at enrollment |
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Total sample size
Last imported at : Aug. 17, 2022, 7 p.m. Source : ClinicalTrials.gov |
473 |
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primary outcome
Last imported at : April 22, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Recovery, assessed at 90 days |
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Notes
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : April 16, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 3 |
|
Arms
Last imported at : April 22, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1679, "treatment_name": "Aviptadil (vasoactive intestinal peptide)+remdesivir", "treatment_type": "Cardiovascular agents+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 155, "treatment_name": "Aviptadil (vasoactive intestinal peptide)", "treatment_type": "Cardiovascular agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |