NCT03376854: CHILL-pilot

Pilot RCT of Therapeutic Hypothermia Plus Neuromuscular Blockade in COVID-19 Patients With ARDS

Withdrawn Phase 2 Last updated 30 April 2021

What this trial tests

Phase 2 trial testing Hypothermia in Respiratory Distress Syndrome, Adult. Withdrawn.

Timeline

1 May 2018

Primary endpoint
27 April 2021

27 April 2021

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 May 2018
Primary completion	27 April 2021
Estimated completion	27 April 2021
Sites	1 location across United States

Drugs / interventions tested

• Hypothermia
• Neuromuscular Blocking Agents — full drug profile →
• Standard of Care

Conditions studied

• Respiratory Distress Syndrome, Adult — all drugs for Respiratory Distress Syndrome, Adult →
• Sars-CoV2 — all drugs for Sars-CoV2 →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 65, any sex, with Respiratory Distress Syndrome, Adult or Sars-CoV2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the investigators sought to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. The investigators are scheduled to begin enrolling in a Department of Defense-funded Phase IIb multicenter RCT of TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients with ARDS with time on ventilator as the primary outcome. Since COVID-19 is now the most common cause of ARDS, we are conducting a pilot study to examine the safety and feasibility of including patients with COVID-19-associated ARDS in our upcoming trial. In this pilot, we will randomize 20 patients with COVID-19 and ARDS to either TH+NMBA for 48h or usual temperature management. The primary outcome is achieving and maintaining the target temperature. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected on days 0, 1, 2, 3, 4, and 7.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Acute respiratory distress syndrome: potential of therapeutic interventions effective in treating progression from COVID-19 to treat progression from other illnesses-a systematic review.
   Ragel EJ, Harris LK, Campbell RA. · · 2023 · cited 8× · PMID 37657844 · DOI 10.1136/bmjresp-2022-001525