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Trial - NCT05152849


Column Value
Trial registration number NCT05152849
Full text link
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT05152849

First author
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Contact
Last imported at : June 8, 2022, 3:30 p.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

2021-12-10

Recruitment status
Last imported at : Oct. 21, 2022, 4 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Long covid

Inclusion criteria
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

inclusion criteria: willing to participate in the study and provide written informed consent male and female adults aged > 18 years and less than 65 years must have had clinically suspected covid-19 and a positive antibody test or a documented sars-cov-2 infection (a positive reverse transcription polymerase chain reaction test) at least 12 weeks prior to screening must have fatigue-predominant pasc other than pasc, a subject must be in good health without other significant medical or not well controlled medical or psychiatric conditions

Exclusion criteria
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

other than pasc, have an explanation for fatigue other than pasc, a history or presence of an uncontrolled, clinically significant disease medical history that includes of non-invasive or invasive ventilatory support for covid 19, intensive care unit or other high dependency unit admission for covid-19, hospitalization for >1 week for covid-19 without intubation

Number of arms
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Axcella Health, Inc

Inclusion age min
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

64

Countries
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

United Kingdom

Type of patients
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Patients recovered from covid

Severity scale
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Oct. 21, 2022, 4 p.m.
Source : ClinicalTrials.gov

41

primary outcome
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Change from baseline at Week 4 in the phosphocreatine (PCr) recovery rate following moderate exercise, as assessed by 31P-magnetic resonance spectroscopy (MRS)

Notes
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Dec. 14, 2021, 1 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2080, "treatment_name": "Axa-1125", "treatment_type": "Metabolic agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]