COVID-19 Treatments

*For monthly updated RCRs, the RCR authors search for new available evidence on a monthly basis. If new evidence is available, an updated report is published. In the case that no new evidence can be identified, no update is published, and the search is repeated in the subsequent month.

For bi-monthly updated RCRs, the RCR authors search for new available evidence every other month. If new evidence is available, an updated report is published. In the case that no new evidence can be identified, no update is published and the search is repeated after 2 months.

Please access a description of methods used in the RCR process here.

Stopping & Starting Rules for RCR

Stopping Rules

• The decision to stop an RCR will be taken collectively in the RCR team.
• A discussion about stopping an RCR will be started when either stopping rule 1 OR stopping rule 2 is met.
• The stopping rules act as orientation/ reference for the discussion in the team; an RCR may not be stopped although one of the rules apply if the team comes to a different conclusion due to any sound reason.

Stopping rule 1:

The compound is in EMA’s marketing authorization process or has a positive marketing authorization decision.

Stopping rule 2:

No clinical benefit: ≥ 2 RCTs OR treatment arms in platform trials (e.g., RECOVERY) with negative efficacy and/or safety results in the indication and population under review (phase III, of high or moderate quality/ high or moderate certainty of evidence, well powered).

OR ≥1 RCT with negative efficacy and/or safety results in the indication and population under review (phase III, of high or moderate quality/ high or moderate certainty of evidence, well powered) AND stopped enrollment of participants to the treatment arm of interest in a platform trial (e.g., RECOVERY) because no evidence of beneficial effects.

• To be considered for the discussion:
  
  • Amount and number of included patients of ongoing RCTs and upcoming RCTs

Starting rules

• The decision to start an RCR will be taken collectively in the RCR team.
• A discussion about starting an RCR will be started when one of the starting rules is met.
• The starting rules act as orientation/ reference for the discussion in the team; an RCR may not be started although one of the rules apply if the team comes to a different conclusion due to any sound reason.

Starting rule 1:

Published results from ≥ 1 phase III RCT with positive efficacy and safety results in the indication and population under review (high or moderate quality, non peer-reviewed or peer-reviewed article).

• Confirmed by DEPLazio or RCT found on covid-nma.com

Starting rule 2:

Upcoming (promising) evidence of ≥ 2 phase III trials.

Starting rule 3:

Compound included as trial drug in a platform trial on COVID-19 treatments.

Starting rule 4:

Combination therapy of ≥ 2 promising pharmaceuticals – the combination will be reviewed as a separate intervention.

Starting rule 5:

Interest from ≥ 2 EUnetHTA Partners (via survey) OR Interest from MAH to seek marketing approval OR Interest from EC, HTA Network or EUnetHTA Stakeholder Groups.

Rapid Collaborative Reviews

Please access the Rapid Collaborative Reviews in the following table.