COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04705831

Maureen Collins

mcollins@immunoe.com

2021-01-12

Unknown

RCT

Randomized

Crossover

Blind label

single-center

Long covid

inclusion criteria: age 18 and older, male or female previous confirmed diagnosis of sars-cov-2 experiencing sars-cov-2 post-viral fatigue syndrome 4 weeks after recovery for sars-cov-2 experiencing neurological symptoms including fatigue willing to comply with all aspects of the protocol, including blood draws patient is able to understand and fully participate in the activities of the study and the consent in accordance with guidelines female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception. acceptable forms of contraception are defined as those with a failure rate of < 1% when properly applied and include: a combination pill, some intra-uterine devices, and a sterilized partner in a stable relationship. female patients must not be pregnant, planning to become pregnant, or be actively breastfeeding through the entire period.

receiving any form of c1-inh therapy either acute or prophylactic treatment history or suspicion of allergy to rabbits neurological conditions related to injury neuropathy related to diabetes participants who are pregnant or lactating largely incapacitated or bed ridden currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study or have discontinued with 30 days of study entry from any other clinical study involving an investigational product patients who, in the investigator's opinion, might not be suitable for the trial for safety reasons

2

IMMUNOe Research Centers

18

75

United States

Patients recovered from covid

N/A

40

Immunological Biomarkers (Com);Immunological Biomarkers (Com);Immunological Biomarkers (Com);Immunological Biomarkers (GAD);Immunological Biomarkers (GAD);Immunological Biomarkers (GAD);Immunological Biomarkers (Ig);Immunological Biomarkers (Ig);Immunological Biomarkers (Ig);Immunological Biomarkers (IgG);Immunological Biomarkers (IgG);Immunological Biomarkers (IgG);Immunological Biomarkers (TH/TH);Immunological Biomarkers (TH/TH);Immunological Biomarkers (TH/TH);Immunological Biomarkers (Toll);Immunological Biomarkers (Toll);Immunological Biomarkers (Toll);Neurological Exam (0);Neurological Exam (17);Neurological Exam (9);Neuropsychological Measures (BDI II);Neuropsychological Measures (BDI II);Neuropsychological Measures (BDI II);Neuropsychological Measures (BRIEF-A);Neuropsychological Measures (BRIEF-A);Neuropsychological Measures (BRIEF-A);Neuropsychological Measures (MoCA);Neuropsychological Measures (MoCA);Neuropsychological Measures (MoCA);Neuropsychological Measures (RBANS);Neuropsychological Measures (RBANS);Neuropsychological Measures (RBANS);Patient-Rate Questionnaires (Activities);Patient-Rate Questionnaires (Activities);Patient-Rate Questionnaires (Activities);Patient-Rate Questionnaires (Activities);Patient-Rate Questionnaires (Activities);Patient-Rate Questionnaires (FSS);Patient-Rate Questionnaires (FSS);Patient-Rate Questionnaires (FSS);Patient-Rate Questionnaires (FSS);Patient-Rate Questionnaires (FSS);Patient-Rate Questionnaires (GSRS);Patient-Rate Questionnaires (GSRS);Patient-Rate Questionnaires (GSRS);Patient-Rate Questionnaires (GSRS);Patient-Rate Questionnaires (GSRS);Patient-Rate Questionnaires (HIT);Patient-Rate Questionnaires (HIT);Patient-Rate Questionnaires (HIT);Patient-Rate Questionnaires (HIT);Patient-Rate Questionnaires (HIT);Patient-Rate Questionnaires (MIDAS);Patient-Rate Questionnaires (MIDAS);Patient-Rate Questionnaires (MIDAS);Patient-Rate Questionnaires (MIDAS);Patient-Rate Questionnaires (MIDAS);Patient-Rate Questionnaires (SF);Patient-Rate Questionnaires (SF);Patient-Rate Questionnaires (SF);Patient-Rate Questionnaires (SF);Patient-Rate Questionnaires (SF);Patient-Rate Questionnaires (SF-36);Patient-Rate Questionnaires (SF-36);Patient-Rate Questionnaires (SF-36);Patient-Rate Questionnaires (SF-36);Patient-Rate Questionnaires (SF-36)

None

Phase 4

[{"arm_notes": "", "treatment_id": 319, "treatment_name": "Conestat alfa", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]