Long COVID Infections and Infestations
Conditions
Interventions
Participants will be randomized 1:1 to one of the following groups:
1. Placebo arm, i.e. patients will receive dummy plasmapheresis treatment with the same setup as the treatment arm but without the r
Sponsors
Academic Hospital Paramaribo
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age =18 years 2. Have had a confirmed SARS-COV2 infection (RT PCR) for at least 6 months 3. Have had at least three of the following symptoms for more than 6 months: fatigue, post-exercise malaise, shortness of breath, headache, diffuse myalgia/arthralgia, neuropathic pain, cognitive impairment, anosmia/ageusia 4. Above symptoms have an impact on daily activities, and/or have been on sick leave for more than 3 months, and/or going to bed for more than 2 hours a day 5. Have given free and informed written consent 6. Affiliated with sickness cost security 7. A score of 6 out of 11 or more on the Chalder fatigue questionnaire and a score of 65 out of 100 or less on the short physical function of 36 subscale 15
Exclusion criteria
Exclusion criteria: 1. With suspicion of COVID-19 but not confirmed by RT-PCR test 2. Known history of any other pathology that could be confused with the diagnosis of long COVID: multiple sclerosis, autoimmune disease (lupus and Gougerot syndrome, inflammatory muscle disease, and myasthenia gravis), untreated hypothyroidism, major depression, regular use of narcotics 3. Unable to travel 4. Congenital or drug-induced coagulation disorders (oral or parenteral anticoagulation) 5. Contraindications to plasmapheresis such as lack of peripheral venous access or unstable cardiac pathology 6. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Long-term COVID symptomatology measured using physical and cognitive questionnaires/parameters (Chalder scale, FAS, Promis) at baseline and 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Observation of the evolution of the fatigue measured by the percentage of patients whose fatigue has decreased by 30% on the Chalder scale at 90 days compared to its initial state measured at baseline 2. Quality of life measured using SF-36 at baseline, day 28 and 90 days 3. Clinical symptoms, functioning, and quality of life evaluated using PROMIS at baseline, day 28 and 90 days 4. Long COVID fatigue symptomology measured by the Fatigue Assessment Scale (FAS) at baseline, day 28 and 90 days 5. Rate and evolution of autoimmune antibody markers within 90 days (posthoc analysis based on funding) analysed with Luminex/ELISA at baseline, day 5, day 10, day 28 and day 90 | — |
Countries
Suriname
Contacts
Public ContactRosita Bihariesingh-Sanchit
Outcome results
None listed