Outcome reporting from protocols of clinical trials of Coronavirus Disease 2019 (COVID-19): a review

Objectives

To examine heterogeneity of outcomes in protocols of clinical trials of Coronavirus Disease 2019 (COVID-19) and to identify outcomes for prioritization in developing a core outcome set (COS) in this field.

Design

This study is a review.

Data sources

Databases of ICMJE-accepted clinical trial registry platform were searched on February 14, 2020.

Eligibility Criteria

Randomized controlled trials (RCTs) and non-RCTs of COVID-19 were considered. Conditions of patients include common type, severe type or critical type. Interventions include traditional Chinese medicine (TCM) and Western medicine. We excluded trials that for discharged patients, psychological intervention and complications of COVID-19.

Data extraction and synthesis

The general information and outcomes, outcome measurement instruments and measurement times were extracted. The results were analysed by descriptive analysis.

Results

19 registry platforms were searched. A total of 97 protocols were included from 160 protocols. For protocols of TCM clinical trials, 76 outcomes from 16 outcome domains were reported, and almost half (34/76, 44.74%) of outcomes were reported only once; the most frequently reported outcome was time of SARS-CoV-2 RNA turns to negative. 27 (27/76, 35.53%) outcomes were provided one or more outcome measurement instruments. 10 outcomes were provided one or more measurement time frame. For protocols of western medicine clinical trials, 126 outcomes from 17 outcome domains were reported; almost half (62/126, 49.21%) of outcomes were reported only once; the most frequently reported outcome was proportion of patients with negative SARS-CoV-2. 27 outcomes were provided one or more outcome measurement instruments. 40 (40/126, 31.75%) outcomes were provided one or more measurement time frame.

Conclusion

Outcome reporting in protocols of clinical trials of COVID-19 is inconsistent. Thus, developing a core outcome set is necessary.

Strengths and limitations of this study

• <label>1.</label>

  This review is the first to describe variation in outcomes, outcome measurement instruments and outcome measurement time reporting in clinical trials for Coronavirus Disease 2019 (COVID-19).

• <label>2.</label>

  All the database of ICMJE-accepted clinical trial registry platform were searched, and randomized controlled trials and observational studies were considered.

• <label>4.</label>

  The aim of this review was to provide a list of outcomes for clinical trials of COVID-19, both interventions of Traditional Chinese Medicine and western medicine were considered.

• <label>5.</label>

  When the searching was conducted, no clinical trials were registered by countries out of China, so all of included protocols were from China.