Identifying clinical solutions for

SARS-CoV-2

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The COVID-19 emergency requires the urgent development of new strategies to protect the population, mainly those most at risk. Since March 2020, a dedicated team of researchers from the STI and Skin NTD Unit has worked to transfer their knowledge on epidemiology into clinical solutions for the Covid-19 pandemic. This work, still on-going, is done thanks to the contribution of citizens (channelled through the #YoMeCorono initiative), and of public and private institutions that are gathering forces to find a treatment for SARS-CoV-2.

Publications

In addition to the Test and Treat and the COnV-ert studies, aimed at identifying clinical solutions against SARS-CoV-2 (listed hereunder as “Therapeutics”), the Unit has performed analyses to advance knowledge in the fields of diagnostics, transmission, and risk factors.

a. Therapeutics

  • Alemany A, Millat-Martinez P, Corbacho-Monné M, Malchair P, Ouchi D, Ruiz-Comellas A, et al. High-titre methylene blue-treated convalescent plasma as an early treatment for outpatients with COVID-19: a randomised, placebo-controlled trial. The Lancet Respiratory Medicine. 2022. [ DOI | ePrint ]

    Convalescent plasma has been proposed as an early treatment to interrupt the progression of early COVID-19 to severe disease, but there is little definitive evidence. We aimed to assess whether early treatment with convalescent plasma reduces the risk of hospitalisation and reduces SARS-CoV-2 viral load among outpatients with COVID-19.

  • Millat-Martinez P, Gharbharan A, Alemany A, Rokx C, Geurtsvankessel C, Papageourgiou G, et al. Prospective individual patient data meta-analysis of two randomized trials on convalescent plasma for COVID-19 outpatients. Nature Communications. 2022;13(1):2583. [ DOI | ePrint ]

    Data on convalescent plasma (CP) treatment in COVID-19 outpatients are scarce. We aimed to assess whether CP administered during the first week of symptoms reduced the disease progression or risk of hospitalization of outpatients. Two multicenter, double-blind randomized trials (NCT04621123, NCT04589949) were merged with data pooling starting when <20% of recruitment target was achieved. A Bayesian-adaptive individual patient data meta-analysis was implemented. Outpatients aged ≥50 years and symptomatic for ≤7days were included. The intervention consisted of 200--300mL of CP with a predefined minimum level of antibodies. Primary endpoints were a 5-point disease severity scale and a composite of hospitalization or death by 28 days. Amongst the 797 patients included, 390 received CP and 392 placebo; they had a median age of 58 years, 1 comorbidity, 5 days symptoms and 93% had negative IgG antibody-test. Seventy-four patients were hospitalized, 6 required mechanical ventilation and 3 died. The odds ratio (OR) of CP for improved disease severity scale was 0.936 (credible interval (CI) 0.667--1.311); OR for hospitalization or death was 0.919 (CI 0.592--1.416). CP effect on hospital admission or death was largest in patients with ≤5 days of symptoms (OR 0.658, 95%CI 0.394--1.085). CP did not decrease the time to full symptom resolution.

  • Mitjà O, Corbacho-Monné M, Ubals M, Alemany A, Suñer C, Tebé C, et al. A Cluster-Randomized Trial of Hydroxychloroquine for Prevention of Covid-19. New England Journal of Medicine. 2021;384(5):417--427. [ DOI | ePrint ]

    Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are limited to nonpharmacologic interventions. Hydroxychloroquine has been proposed as a postexposure therapy to prevent coronavirus disease 2019 (Covid-19), but definitive evidence is lacking. (Funded by the crowdfunding campaign YoMeCorono and others; BCN-PEP-CoV2 ClinicalTrials.gov number, NCT04304053.)

  • Mitjà O, Corbacho-Monné M, Ubals M, Tebé C, Peñafiel J, Tobias A, et al. Hydroxychloroquine for Early Treatment of Adults With Mild Coronavirus Disease 2019: A Randomized, Controlled Trial. Clinical Infectious Diseases. 2020 07;73(11):e4073--e4081. [ DOI | ePrint ]

    No effective treatments for coronavirus disease 2019 (COVID-19) exist. We aimed to determine whether early treatment with hydroxychloroquine (HCQ) would be efficacious for outpatients with COVID-19.Multicenter open-label, randomized, controlled trial conducted in Catalonia, Spain, between 17 March and 26 May 2020. Patients recently diagnosed with
    <5-day of symptom onset were assigned to receive HCQ (800 mg on day 1 followed by 400 mg once daily for 6 days) or usual care. Outcomes were reduction of viral load in nasopharyngeal swabs up to 7 days after treatment start, disease progression up to 28 days, and time to complete resolution of symptoms. Adverse events were assessed up to 28 days.A total of 293 patients were eligible for intention-to-treat analysis: 157 in the control arm and 136 in the intervention arm. The mean age was 41.6 years (SD, 12.6), mean viral load at baseline was 7.90 log10 copies/mL (SD, 1.82), and median time from symptom onset to randomization was 3 days. No differences were found in the mean reduction of viral load at day 3 (−1.41 vs −1.41 log10 copies/mL in the control and intervention arm, respectively) or at day 7 (−3.37 vs −3.44). Treatment did not reduce risk of hospitalization (7.1
    % control vs 5.9
    % intervention) nor shorten the time to complete resolution of symptoms (12 days, control vs 10 days, intervention). No relevant adverse events were reported.In patients with mild COVID-19, no benefit was observed with HCQ beyond the usual care.

b. Diagnostics

  • Alemany A, Baró B, Ouchi D, Rodó P, Ubals M, Corbacho-Monné M, et al. Analytical and clinical performance of the panbio COVID-19 antigen-detecting rapid diagnostic test. Journal of Infection. 2021 May;82(5):186--230. [ DOI | ePrint ]

  • Alemany A, Millat-Martinez P, Ouchi D, Corbacho-Monné M, Bordoy AE, Esteban C, et al. Self-collected mid-nasal swabs and saliva specimens, compared with nasopharyngeal swabs, for SARS-CoV-2 detection in mild COVID-19 patients. Journal of Infection. 2021 Dec;83(6):709--737. [ DOI | ePrint ]

    Self-collected nasal and saliva samples can be used for SARS-CoV-2 screening.?Self-collected nasal and saliva specimens had a 99% and 90% sensitivity, respectively.?Nasopharyngeal swab viral loads correlate better with nasal than saliva.?Viral load correlations are poorer at day 7, when lower viral loads are observed.

  • Baro B, Rodo P, Ouchi D, Bordoy AE, Saya Amaro EN, Salsench SV, et al. Performance characteristics of five antigen-detecting rapid diagnostic test (Ag-RDT) for SARS-CoV-2 asymptomatic infection: a head-to-head benchmark comparison. Journal of Infection. 2021. [ DOI | ePrint ]

    Background Mass testing for early identification and isolation of infectious COVID-19 individuals is efficacious for reducing disease spread. Antigen-detecting rapid diagnostic tests (Ag-RDT) may be suitable for testing strategies; however, benchmark comparisons are scarce. Methods We used 286 nasopharyngeal specimens from unexposed asymptomatic individuals collected between December 2020 and January 2021 to assess five Ag-RDTs marketed by Abbott, Siemens, Roche Diagnostics, Lepu Medical, and Surescreen. Results For the overall sample, the performance parameters of Ag-RDTs were as follows: Abbott assay, sensitivity 38.6Conclusions When screening unexposed asymptomatic individuals, two Ag-RDTs achieved sensitivity ≥80% for specimens with Ct<30 and specificity ≥96%. The estimated negative predictive value suggests the suitability of Ag-RDTs for mass screenings of SARS-CoV-2 infection in the general population.

c. Transmission

  • Suñer C, Coma E, Ouchi D, Hermosilla E, Baro B, Rodríguez-Arias MÀ, et al. Association between two mass-gathering outdoor events and incidence of SARS-CoV-2 infections during the fifth wave of COVID-19 in north-east Spain: A population-based control-matched analysis. The Lancet Regional Health -- Europe. 2022 Apr;15. [ DOI | ePrint ]

    Many countries have resumed mass-gathering events like music festivals, despite the risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreading. In this study, we aimed to assess the effect of two mass-gathering outdoor events, held during a peak of SARS-CoV-2 transmission, on COVID-19 incidence.

  • Marks M, Millat-Martinez P, Ouchi D, Roberts Ch, Alemany A, Corbacho-Monné M, et al. Transmission of COVID-19 in 282 clusters in Catalonia, Spain: a cohort study. The Lancet Infectious Diseases. 2021;21(5):629--636. [ DOI | ePrint ]

    Scarce data are available on what variables affect the risk of transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the development of symptomatic COVID-19, and, particularly, the relationship with viral load. We aimed to analyse data from linked index cases of COVID-19 and their contacts to explore factors associated with transmission of SARS-CoV-2.

d. Risk factors

  • Suñer C, Ouchi D, Mas MÀ, Lopez Alarcon R, Massot Mesquida M, Prat N, et al. A retrospective cohort study of risk factors for mortality among nursing homes exposed to COVID-19 in Spain. Nature Aging. 2021;1(7):579--584. [ DOI | ePrint ]

    Long-term care (LTC) facilities have shown remarkably high mortality rates during the coronavirus disease 2019 (COVID-19) outbreak in many countries1, and different risk factors for mortality have been identified in this setting2--5. Using facilities as the unit of analysis, we investigated multiple variables covering facility characteristics and socioeconomic characteristics of the geographic location to identify risk factors for excess mortality from a comprehensive perspective. Furthermore, we used a clustering approach to detect patterns in datasets and generate hypotheses regarding potential relationships between types of nursing homes and mortality trends. Our retrospective analysis included 167 nursing homes providing LTC to 8,716 residents during the COVID-19 outbreak in Catalonia (northeast Spain). According to multiple regression analysis, COVID-19-related and overall mortality at the facility level were significantly associated with a higher percentage of patients with complex diseases, lower scores on pandemic preparedness measures and higher population incidence of COVID-19 in the surrounding population. When grouping nursing homes into eight clusters based on common features, we found higher mortality rates in four clusters, mainly characterized by a higher proportion of residents with complex chronic conditions or advanced diseases, lower scores on pandemic preparedness, being located in rural areas and larger capacity, respectively.

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Collaborators

Grifols
Caixa
Teixits
Isglobal
YoMeCorono
BSC
Institut
Cresa
Hostpital