COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05171920

Sudarshan Hebbar

Not reported

2021-12-29

Withdrawn

RCT

Randomized

Sequential assignment

Blind label

multi-center

Treatment

inclusion criteria: has laboratory-confirmed sars-cov-2 infection as determined by polymerase chain reaction (pcr) or other commercial or public health assay in any specimen, as documented by either of the following: pcr positive in sample collected < 72 hours prior to consent; pcr positive in sample collected ≥ 72 hours prior to consent, with inability to obtain a repeat sample (e.g. due to lack of testing supplies, or limited testing capacity, or results taking >24 hours, etc.) or progressive disease suggestive of ongoing sars-cov-2 infection; at least 1 of the following symptoms: o fever, cough, sore throat, malaise, headache, muscle pain, dyspnea at rest or with exertion, confusion, or respiratory distress; a pao2/fio2 ≤200 recorded in the 24 hours before consent. the pao2/fio2 can be imputed from pulse oximetry; oxygen therapy being administered via hfnc or niv the presence of a respiratory infiltrate or abnormality consistent with pneumonia that is documented by either a cxr or ct scan of the lungs; the patient is ≥18 years of age; a female patient of childbearing potential must not attempt to become pregnant for 180 days, and if sexually active with a male partner, is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug; a male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 180 days after the last dose of study drug. a male patient must not donate sperm for 180 days; the patient is willing and able to, or has a legal authorized representative (lar) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.

do not intubate order; pao2/fio2 ≤75 recorded at the time of consent. the pao2/fio2 can be imputed from pulse oximetry; receiving imv via endotracheal intubation or tracheostomy; receiving ecmo; shock defined by the use of vasopressors; known history of: organ or hematologic transplant; hiv; active hepatitis b, or hepatitis c infection; current treatment with: chemotherapy; immunosuppressive medications or immunotherapy (see protocol (section 5.3) for list of prohibited immunosuppressive medications and immunotherapy) at the time of consent; hemodialysis or peritoneal dialysis; known to be pregnant or is nursing; currently participating in another study of an investigational drug or therapeutic medical device at the time of consent; known allergy to eggs or any of the excipients in study drug.

2

CalciMedica, Inc.

18

100

United States

Severe disease at enrollment

6: Severe disease at enrollment

0

Proportion of randomized patients receiving 6 versus 3 doses of Auxora requiring IMV or dying after 72 hours from the SFIA through day 60.

None

Phase 2

[{"arm_notes": "", "treatment_id": 151, "treatment_name": "Auxora", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]