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| Column | Value |
|---|---|
| Trial registration number | NCT05445674 |
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Full text link
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 18, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 18, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
2022-07-06 |
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Recruitment status
Last imported at : June 8, 2023, noon Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Long covid |
|
Inclusion criteria
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
inclusion criteria: male or female individuals 18 years-old or older. evidence of previous sars-cov-2 infection at least 90 days prior to study recruitment, defined by either (a) nasopharyngeal sars-cov-2 nucleic acid test (polymerase chain reaction [pcr] or transcription-mediated amplification [tma] (b) validated nasopharyngeal lateral flow assay rapid antigen test [rat], or (c) sarscov-2 serology before sars-cov-2 vaccination. symptoms of pcc after 90 days of infection and that last for at least 2 months and cannot explained by an alternative diagnosis. not able to perform all usual duties/ activities due to symptoms, pain, depression or anxiety, defined as grades 3 or 4 in the post-covid-19 functional status (pcfs) scale. availability of an adequate peripheral venous cannulation. if women of childbearing potential, use of a highly effective method of contraception (abstinence, hormonal contraception, intra-uterine device [iud], or anatomical sterility in self). willing to comply with the requirements of the protocol and available for followup for the planned duration of the study. has understood the information provided and capable of giving informed consent. exclusion criteria |
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Exclusion criteria
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
sars-cov-2 infection diagnosed during the previous 90 days. last sars-cov-2 vaccine dose during the previous 30 days. no significant limitations in the subject's ability to perform all usual duties/activities (i.e., grades 0, 1 or 2 in pcfs scale). medical conditions for which 250 ml of intravenous fluid is considered dangerous (i.e., decompensated heart failure or renal failure with fluid overload, among others). pregnant or breastfeeding women. contraindications for therapeutic pe: non-availability of an adequate peripheral venous catheter, hemodynamic instability, septicemia, known allergy to fresh frozen plasma or replacement colloid/albumin, known allergy to heparin. current or planned hospital admission for any cause during the study follow-up. inability to consent and/or comply with study requirements, in the opinion of the investigator. currently participating or planning to participate in any other clinical trial until day 90 of follow-up. |
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Number of arms
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia |
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Inclusion age min
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Spain |
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Type of patients
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Patients recovered from covid |
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Severity scale
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
50 |
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primary outcome
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Evaluate the safety and tolerability of PE in patients with Post-Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange (placebo);Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the fatigue severity scale (FSS);Proportion of subjects with Grade 0, 1 o 2 functional disability assessed by the functional status scale (PCFS) |
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Notes
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
Phase 2 |
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Arms
Last imported at : July 8, 2022, midnight Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1000, "treatment_name": "Plasma exchange", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |