Table 3.
Recommended study designs for COVID-19
| Key question(s) | Recommended study design and associated resources |
|---|---|
| What is the clinical presentation and spectrum of disease? |
Patient cohorts or patient registry. |
| Resource for hospitalised cases: Modified ISARIC/WHO Clinical Characterization protocol using new CRF form for COVID-19 (https://isaric.tghn.org/novel-coronavirus/) | |
|
The First Few X (FFX) WHO Protocol https://www.who.int/publications-detail/the-first-few-x-(ffx)-cases-and-contact-investigation-protocol-for-2019-novel-coronavirus-(2019-ncov)-infection) | |
| What are the risk factors for death or severe illness? |
Case-control study or prospective cohort with outcome of death or another defined poor outcome |
| What treatments are effective? |
Randomised controlled trials or adaptive trial designs |
| What is the role of antivirals in treatment? |
WHO Master Protocol: https://www.who.int/blueprint/priority-diseases/key-action/multicenter-adaptive-RCT-of-investigational-therapeutics-for-COVID-19.pdf?ua=1 |
| What is the role of steroids in treatment? | |
| What is the optimal diagnostic test for detecting the virus? |
Diagnostic validation studies with clinical specimens |
| What is the duration of viral shedding? |
Prospective cohort with systematic serial collection of specimens |
| Resource for hospitalised cases: ISARIC/WHO Clinical Characterization protocol (https://isaric.net/ccp) | |
| What characteristics define a “case”? |
Clinical or population-based cohorts |
| Resource for hospitalised cases: ISARIC/WHO Clinical Characterization protocol (https://isaric.net/ccp) | |
| The First Few X (FFX) WHO Protocol | |
| What are the risk factors which pre-dispose health care workers to infection or transmission? | HCW cohort studies or case-control studies |
| Resource: WHO HCW risk factor protocol (https://www.who.int/publications-detail/protocol-for-assessment-of-potential-risk-factors-for-2019-novel-coronavirus-(2019-ncov)-infection-among-health-care-workers-in-a-health-care-setting) | |
| What are the risk factors for infection? (patient population) | Patient cohort |
| Resource: The First Few X (FFX) WHO Protocol | |
| What are the psychosocial consequences of infection with the virus? |
Mixed methods study (survey + qualitative interviews) |
| What is the causative agent of disease? | Laboratory based study with clinical specimens, fulfilling Koch’s postulates |