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Comparison · NCT04308668-a6bbf69b

Treatment vs Placebo: Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Treatment vs Placebo: Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry. Trial comparisons, record NCT04308668-a6bbf69b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04308668-a6bbf69b

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.02160.009280.0497wilson
Risk in group 20.03420.01740.066wilson
Risk difference, group 1 minus group 2-0.0125-0.04670.0201newcombe hybrid score
Risk ratio, group 1 over group 20.6330.211.91log
Odds ratio, group 1 over group 20.6250.2011.94log
Number needed to treat, for one fewer participant with the outcome on Treatment than on Placebo79.7from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1TreatmentParticipants in this arm will receive the study drug.~Hydroxychloroquine: 200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days5231OG000
Group 2PlaceboParticipants in this arm will receive a placebo treatment.~Placebo: 4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days8234OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Severe COVID-19 Disease at 14 Days Among Those Who Are Symptomatic at Trial Entry
Description
Participants will self-report disease severity status as one of the following 3 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization or death (score of 3). Increased scale score indicates greater disease severity. Outcome is reported as the number of participants who report a score of 3.
Time frame
14 days
Population

Source ClinicalTrials.gov

Trial

Title
Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coronavirus-2
NCT number
NCT04308668
Phases
PHASE3
Conditions
Corona Virus Infection, Acute Respiratory Distress Syndrome, SARS-CoV Infection, Coronavirus, Coronavirus Infections
Interventions
Hydroxychloroquine, Placebo
Lead sponsor
University of Minnesota
Results first posted
2021-05-13

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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