Ruxolitinib therapy to Avoid Ventilation and improve outcome for deteriorating COVID-19 patients

Phase 1

• Conditions: Severe COVID-19 infection with risk of need for mechanical ventilation.; MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001777-71-GB
• Lead Sponsor: Guy’s and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-30
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1.Patients admitted to Guy’s and St. Thomas’ NHS Foundation Trust with swab proven COVID-19
2.Deemed eligible at the time of admission for escalation to mechanical ventilation if required.
3.Worsening clinical and laboratory features suggestive of COVID-19 disease progression:
‘Yellow or Amber Category’ as judged on the current GSTT action card 21: Adult Escalation Plan for Patients with Confirmed or Suspected Covid-19 despite optimisation (example in Figure 2)
–and
have respiratory rate >/= 20 at any time in 24 hours prior to recruitment.
-and
At least two of either:
CRP: >100
or
Serum ferritin levels >1000ng/mL
or
D-dimer raised >1 µg/mL
4.Greater than 18 years of age and ability to grant full consent for repurposed use of ruxolitinib
5.No excluded concomitant medication
6.Written informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 59

Exclusion Criteria

1.Those patients below age 18 years of age
2.Not proven to have COVID-19 disease
3.Inability to grant informed consent
4.Not meeting the inclusion criteria for both clinical and biochemical features as above.
5.Pregnant or lactating and breast-feeding women
6.Unwilling to use contraception as detailed in section 5.3
7.Neutrophil counts <1.0X109/L or platelets <100x109/L
8.Inadequate liver function as defined by ALT/AST >5 x ULN
9.Inadequate renal function as defined by GFR < 30 mls/min
10.Patients already taking JAK inhibitor therapy
11.Patients currently enrolled in another study of an investigational medicinal product. Of note, treatment with the antiviral agent remdesivir is permitted.
12.Any known contraindication or hypersensitivity to JAK inhibitor therapy (or any of the IMP excipients) such as untreated active hepatitis B or HIV

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified