Here is the design of a clinical trial:

Official Title: Re-EValuating the Inhibition of Stress Erosions: Prophylaxis Against Gastrointestinal Bleeding in the Critically Ill (The REVISE) Trial

Included conditions:
- Gastrointestinal Hemorrhage (Clinically Important, Upper)

Study Armgroups:
- {'label': 'Placebo (0.9% saline)', 'type': 'PLACEBO_COMPARATOR', 'description': 'Withholding Stress ulcer prophylaxis (intravenous 0.9% saline as placebo)', 'interventionNames': ['Drug: Placebo (0.9% saline)']}
- {'label': 'Stress Ulcer Prophylaxis (Pantoprazole)', 'type': 'ACTIVE_COMPARATOR', 'description': 'pantoprazole 40mg powder for injection reconstituted with 0.9% saline', 'interventionNames': ['Drug: Pantoprazole']}

Interventions:
- {'type': 'DRUG', 'name': 'Placebo (0.9% saline)', 'description': 'normal saline', 'armGroupLabels': ['Placebo (0.9% saline)'], 'otherNames': ['normal saline; NaCl 0.9%']}
- {'type': 'DRUG', 'name': 'Pantoprazole', 'description': '40 mg powder for injection reconstituted with 0.9% saline', 'armGroupLabels': ['Stress Ulcer Prophylaxis (Pantoprazole)'], 'otherNames': ['Protonix']}

Primary Outcomes:
- {'measure': 'Rate of clinically important upper gastro-intestinal bleeding', 'description': 'Clinically important upper GI bleeding requires the presence of overt GI bleeding which is defined as one of the following;\n\n* Hematemesis\n* Overt nasogastric bleeding\n* Melena\n* Hematochezia\n\nPLUS (in the absence of another cause), at least one of the following in the 24 hours following overt GI bleeding:\n\n* Haemodynamic change defined as a spontaneous decrease in invasively monitored mean arterial pressure or non-invasive systolic or diastolic blood pressure of 20 mmHg or more or an orthostatic increase in pulse rate of 20 beats/minute and a decrease in systolic blood pressure of 10 mmHg, with or without vasopressor initiation, or increase\n* Vasopressor initiation\n* A decrease in haemoglobin of ≥ 20 g/l in a 24-hour period or less,\n* Transfusion of ≥2 units of packed red blood cells within 24 hours of bleeding to maintain stable haemoglobin or haemodynamics, or\n* Need for therapeutic intervention (e.g. angiography, surgery or endoscopic treatment of bleeding).', 'timeFrame': '90 days (In ICU or resulting in ICU readmission, censored at 90 days after randomization)'}
- {'measure': 'Primary Safety Outcome: 90 Day Mortality', 'description': 'Mortality status at day 90 post randomization', 'timeFrame': '90 days post randomization'}

Please estimate the sample size based on the assumption: 
Baseline characteristics will be described, and multiple imputation will be performed for outcomes missing in more than 2% of patients. No adjustments for multiple comparisons will be made. Analyses will be performed using SAS version 9.4.
Sample size
          The cohort size is based on the number of patients with COVID-19 enrolled in REVISE. As of June 1, 2023, 484 patients with COVID-19 have been enrolled in REVISE, representing 10.1% of the sample size of 4800 patients. Acknowledging the inherent challenges in predicting the incidence of and the meansâÂ±âstandard deviation (SD) or median (interquartile range [IQR]) of the continuous variables will be calculated. Baseline characteristics (e.g., age, sex, APACHE II Score, admission diagnostic category, comorbidities, COVID-19 vaccination status, and pre-hospital acid suppression) will be described. Table 1 presents the statistical analysis plans for the 3 study objectives, hypotheses, and outcomes.
          For any outcome that is missing for more than 2% of patients, we will perform multiple imputation. Adjustments for multiple comparisons will not be made for these exploratory analyses. All analyses will be performed using the statistical software SAS version 9.4 [21].