Table 2.
Details of clinical trial
|
Arm
|
Intervention/Treatment
|
NCT04455243 | Experimental: Intervention group | Drug N-acetylcysteine is given as 150 mg/kg q 12 h PO or IV every 12 h for 14 d diluted in 200 mL diluent (D5 % NS) |
Placebo comparator: Control group | Matching drug placebo is administered in the same schedule and volume as N-acetylcysteine | |
NCT04374461 | Experimental: Arm A. (1) Transfer out of the critical care unit; (2) Extubation; (3) Toxicity; and (4) Death | Drug NAC. Others: Peripheral blood dosages are given in both groups as mentioned above |
Experimental: Arm B. (1) Discharge from the hospital; (2) Admission to a critical care unit; (3) Intubation; (4) Toxicity; and (5) Death | Drug NAC. Others: Peripheral blood dosage details as mentioned above | |
NCT04419025 | Active Comparator: NAC Patients receiving N-acetylcysteine | Drug: N-acetylcysteine. In-patient: (1) Oral formulation 600 mg capsules of NAC q4 h until discharge; and (2) 1200 mg PO BID × 1-wk post-discharge Outpatient :2400 mg PO × 1 then 1200 mg PO BID × 2 wk |
No Intervention: Control patients not receiving N-acetylcysteine | ||
NCT04458298 | Experimental: Cohort A: OP-101 2 mg/kg. Participants will receive a single intravenous (IV) infusion of OP-101 2 milligram per kilogram (mg/kg) on Day 1 | Drug: OP-101 will be administered as an IV infusion |
Experimental: Cohort B: OP-101 4 mg/kg. Participants will receive a single IV infusion of OP-101 4 mg/kg on Day 1 | Drug: OP-101 will be administered as an IV infusion | |
Experimental: Cohort C: OP-101 8 mg/kg Participants will receive a single IV infusion of OP-101 8 mg/kg on Day 1 | Drug: OP-101 will be administered as an IV infusion | |
Placebo Comparator: Cohort D: Placebo Participants will receive a single IV infusion of matching placebo on Day 1 | Drug: Placebo. Matching placebo infusion will be administered intravenously |
PO: Peros; NAC: N-acetylcysteine; NAC: N-acetylcysteine; BID: Bisindie; PO: Peros.