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Table 3 Endpoints and data analysis plan

From: Hormonal intervention for the treatment of veterans with COVID-19 requiring hospitalization (HITCH): a multicenter, phase 2 randomized controlled trial of best supportive care vs best supportive care plus degarelix: study protocol for a randomized controlled trial

Endpoint analyses

Statistical methods

SAS procedures

Primary endpoint

A composite endpoint of mortality, hospital stay rate, and ECMO or mechanical intubation at 15 days after randomization

Pearson chi-square tests or Fisher exact tests

Logistic regression adjusted for age, hypertension, and COPD

PROC FREQ

PROC LOGISTC

Secondary endpoints

1. Time to the clinical improvement

2. Inpatient mortality

3. Length of hospital stay

4. Duration of intubation for mechanical ventilation

5. Time to normal temperature

6. Maximum severity of COVID-19 illness

1. Log-rank test, Kaplan-Meier curves

Cox regression adjusted for age, hypertension, and COPD

2. Pearson chi-square tests or Fisher exact tests

Logistic regression adjusted for age, hypertension, and COPD

3. Wilcoxon test; quantile regression

4. Wilcoxon test; Quantile regression

5. Log-rank test, Kaplan-Meier curves

Cox regression adjusted for age, hypertension, and COPD

6. Pearson chi-square test; Cochran–Armitage trend test

Proportional odds logistic regression

1. PROC LIFETEST

PROC PHREG

2. PROC FREQ

PROC GENMOD

3. PROC NPAR1WAY

4. PROC NPAR1WAY

5. PROC LIFETEST

PROC PHREG

6. PROC FREQ

PROC LOGISTC

Exploratory analyses

 Clinical prognostic factors

 Laboratory prognostic factors

 Viral load

 Cytokines levels and TMPRSS2 expression

 Germline genomic factors

1. Time to event data

Log-rank tests, Kaplan-Meier curves, and Cox regressions

2. Categorical data

Pearson chi-square tests and logistic regression

3. Interval data

Student t/Wilcoxon tests, linear or quantile regressions

4. Longitudinal data

Mixed-effect model repeated measure

1. PROC LIFETEST

PROC PHREG

2. PROC FREQ

PROC LOGISTC

3. PROC TTEST

PROC NPAR1WAY

4. PROC Mixed

AE/SAE analyses

1. Incidence of AE/SAE

2. Frequency difference of AE and SAE

3. AE /SAE by relationship to the treatment

4. AE/SAE leading to premature discontinuation

For All AE/SAE

Incidence rate estimation and testing

Pearson chi-square tests or Fisher exact tests

PROC FREQ

SAS Macros

Other analyses

1. Baseline characteristics

2. Disposition status

3. Adherence

4. Site Effect

1. Student t or Wilcoxon tests,

Pearson chi-square or Fisher exact tests

2. Pearson chi-square tests

3. Pearson chi-square tests

4. Pearson chi-square tests, Student t or Wilcoxon tests, log-rank test

1. PROC TTEST,

PROC FREQ,

PROC NPAR1WAY

2. PROC FREQ

3. PROC FREQ

4. PROC FREQ

PROC LIFETEST

PROC NPAR1WAY