| Participants |
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 (PCR or TMA) (b) validated nasopharyngeal lateral flow assay RAT, or (c) SARS‐CoV‐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 be 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 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, intrauterine device, or anatomical sterility in self). Willing to comply with the requirements of the protocol and available for follow‐up for the planned duration of the study. Has understood the information provided and capable of giving informed consent.
Exclusion criteria:
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 person'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, amongst others). Pregnant or breastfeeding women. Contraindications for therapeutic PE: non‐availability of an adequate peripheral venous catheter, haemodynamic instability, septicaemia, 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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| Interventions |
Experimental arm: plasma exchanges will be performed with 5% albumin as the replacement fluid. The typical schedule prescribed will be an exchange of 1 volaemia. Blood will be separated into cells and plasma; the cells will be combined with reconstituted 5% human serum albumin and reinfused into the participant with normal saline.
Plasma exchange sessions will occur on days 1, 3, 8, 10, 15, and 17.
Control arm: sham plasma exchange procedures, involving a sound behind the curtain performed imitating the sound of the cell processing platform. In these cases, only 1 infusion of 200 to 250 mL of sterile saline solution 0.9% will be performed during the time established for all procedures.
Sham plasma exchange sessions will occur on days 1, 3, 8, 10, 15, and 17. |
| Outcomes |
Primary outcomes:
Proportion of adverse events through day 90 Proportion of participants with Grade 0, 1, or 2 functional disability assessed by the PCFS scale Proportion of participants with Grade 0, 1, or 2 functional disability assessed by the FSS
Secondary outcomes:
Assess the ability of PE to improve PCC symptoms [Time Frame: At days 0, 8, 15, 22, 45, and 90] Assess the impact of PE on quality of life in participants with PCC [Time Frame: At day 0, 8, 15, 22, 45, and 90]
Quality of life questionnaires: EQ‐5D questionnaire, with 5 the better outcome and 15 the worse outcome
Assess the impact of PE on quality of life in participants with PCC using MOS‐HIV [Time Frame: At day 0, 8, 15, 22, 45, and 90]
Quality of life questionnaires: MOS‐HIV questionnaire, with 4 the better outcome and 1 the worse outcome
The neurocognitive evaluation assessed by the NeuScreen fluency test (Seconds)
The neurocognitive evaluation assessed by questionnaire, with 0 the better outcome and 120 the worst outcome
The neurocognitive evaluation assessed by the HADS questionnaire, with 0 the better outcome and 21 the worst outcome
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the determination of SARS‐CoV‐2 specific IgG [Time Frame: At day 0, 8, 15, 22, 45, and 90]
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the determination of SARS‐CoV‐2 specific igG in plasma (Arbitrary Units, AU)
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the neutralization activity evaluation [Time Frame: At day 0, 8, 15, 22, 45, and 90]
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the analysis of reciprocal titres of neutralizing antibodies against SARS‐CoV‐2
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the T‐cell response [Time Frame: At day 0, 8, 15, 22, 45, and 90]
Changes in cellular anti‐SARS‐CoV‐2 immunity associated with PE in participants with PCC by the reduction of T‐cell response (%) from plasma samples
Determination of residual SARS‐CoV‐2 particles RNA in plasma from participants with PCC [Time Frame: At days 0, 8, 15, 22, 45, and 90]
Virological assessment to determine the residual SARS‐CoV‐2 RNA (copies/mL)
Changes in microbiota associated with PE in participants with PCC [Time Frame: At day 1, 8, 15, 22, 45, and 90]
Stool assessment to determine the residual SARS‐CoV‐2 RNA (copies/mL) |
