Here is the design of a clinical trial:

Official Title: Pyridostigmine in Patients With Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2 Infection

Included conditions:
- COVID-19
- SARS-CoV-2

Study Armgroups:
- {'label': 'Pyridostigmine', 'type': 'ACTIVE_COMPARATOR', 'description': 'Pyridostigmine bromide tablet (60mg P.O. once per day for 14 days)', 'interventionNames': ['Drug: Pyridostigmine Bromide']}
- {'label': 'Placebo', 'type': 'PLACEBO_COMPARATOR', 'description': 'Placebo tablet (60mg P.O. once per day for 14 days)', 'interventionNames': ['Drug: Placebo']}

Interventions:
- {'type': 'DRUG', 'name': 'Pyridostigmine Bromide', 'description': 'One 60mg tablet P.O. once per day for 14 days', 'armGroupLabels': ['Pyridostigmine'], 'otherNames': ['Mestinon', 'Pyridostigmine']}
- {'type': 'DRUG', 'name': 'Placebo', 'description': 'One tablet P.O. once per day for 14 days', 'armGroupLabels': ['Placebo'], 'otherNames': ['Starch (pharmaceutical grade)']}

Primary Outcomes:
- {'measure': 'Critical condition or death', 'description': 'Composite of death, Need for mechanical ventilation, or an increase of 2 or more points in the SOFA score', 'timeFrame': '28 days'}
- {'measure': 'IL-6', 'description': 'Kinetics of circulating IL-6', 'timeFrame': '14 days in-hospital, hospital discharge, or death'}

Please estimate the sample size based on the assumption: 
First phase: One-sided 80% confidence limit. Second phase: 80% power, 0.05 significance level, two-sided t-test, 10% dropout rate.
Sample size
        
          First (security) phase
          We estimate that a sample size of 40 participants (20 in each group) would produce a one-sided 80% confidence limit that would exclude us finding a 10%-point difference that would be statistically significant in the complete trial [15]. However, calculating a 10% loss, we will recruit 44 participants for this part of the study.
        
        
          Second phase
          We estimate that a sample size of 436 participants (218 per group) estimating a 10% reduction in the occurrence of the primary outcome in the intervention group to be clinically significant. Based on recent evidence from China, we estimate that 25% of patients hospitalized with severe SARS-CoV-2 infection will develop complications leading to the need of invasive mechanical ventilation or death [16] Accordingly, we estimate that this sample size will allow us to identify with an 80% power a reduction in the need of invasive mechanical ventilation or death of 10% in the group receiving pyridostigmine in comparison with the group on placebo, using a two-sided t-test at the 0.05 significance level.