COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04344184

Markos G Kashiouris

mkashiouris@vcu.edu

2020-04-14

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: adults of 18 years or older patients hospitalized with a diagnosis of covid-19 based on central laboratory-confirmed covid-19 novel coronavirus disease-2019, based on a positive sars-cov-2 rt-pcr confirmed within 72 hours prior to enrollment of nasal, oropharyngeal, or bal specimen with hypoxemia, (i.e., decrease in oxygenation, as outlined below) pulse oximetry saturation (spo2) < 93% on room air in who covid-19 ordinal scale 3 patients, regardless the need for assisted ventilation, or oxygenation. any new requirement of supplemental oxygen, with any oxygen device (who covid-19 ordinal scale 4-7, regardless of pulse oximetry reading) in patients with supplemental oxygen at home, any increase in the requirement of supplemental oxygen. in icu level care

age less than 18 years known allergy to vitamin c inability to obtain consent from patient or next of kin presence of diabetic ketoacidosis any history of oxalate stones at any time patients with kidney disease improving global outcomes (kdigo), ckd stage 4 (egfr < 30 ml/min, ckd stage 5 and end-stage renal disease on dialysis patients are excluded. patients with acute kidney injury, stage 3. pregnant, or lactating known diagnosis of glucose-6-phosphate dehydrogenase (g6pd) deficiency patients who received the following medications within 7 days prior to enrollment, or plan to receive during enrollment, or 7 days after enrollment: aluminum hydroxide, bortezomib, copper, deferoxamine, amphetamines including derivatives such as fluphenazine. patients with active sickle cell crisis prisoners patients outside icu level care

2

Virginia Commonwealth University

18

None

United States

Severe disease at enrollment

6: Severe disease at enrollment

47

Change in COVID disease status

None

Phase 2

[{"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]