Medicine

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    Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial
    (BioMed Central, 2020) Niriella, M.A.; Ediriweera, D.S.; de Silva, A.P.; Premaratna, R.; Balasooriya, P.; Duminda, K.D.; Malavige, N.G.; Wanigasuriya, K.; Lekamwasam, S.; Kularathne, S.A.; Siribaddana, S.; de Silva, H.J.; Jayasinghe, S.
    BACKGROUND: The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients. METHODS/DESIGN: This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days. DISCUSSION: This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011. Registered on 04 May 2020. KEYWORDS: COVID-19; HCQ; Hydroxychloroquine; Post-exposure; Prophylaxis; Randomized controlled trial; SARS-CoV-2; Sri Lanka.
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    Rickettsial disease IFA-IgG titres in auto-immune diseases: What do they imply?
    (Elsevier, 2016) Balasooriya, P.; Bandara, N.B.; Chandrasena, T.G.A.N.; Premaratna, R.
    BACKGROUND: Rickettsial infections are known to present mimicking autoimmune disorders. The gold standard diagnostic test for rickettsial diseases is based on the detection of IgM and or IgG antibodies against these infections by immuno-fluorescent technique (IFA). While confirmation of rickettsial diseases warrant demonstration of rising or declining antibody titres between acute and convalescent samples, high titres of either IFA-IgM or IFA-IgG in acute phase serum in patients with a compatible clinical illness may help in the presumptive diagnosis and introduction of anti-rickettsial antibiotics. During the IFA test, patient sera containing anti rickettsial antibodies are made to react with rickettsial antigens that are grown in cell culture media. However, presence of nuclear material in these cell cultures may react with anti-nuclear antibodies that are produced in autoimmune disorders and cause a false positive immunofluorescent signal. METHODS & MATERIALS: In order to evaluate the reactivity of rickettsial disease IFA-IgG test [IFA-IgG-OT (Orientia tsutsugamushi) and IFA-IgG-SFG (spotted fever group)] among patients with autoimmune diseases, an analytical cross-sectional study was carried out using sera of 38 patients with confirmed auto-immune diseases. RESULTS: The 38 patients included 15 systemic lupus erythematosus (SLE), 5 autoimmune-thyroiditis, 13 idiopathic-thrombocytopenia (ITP), 4 autoimmune-haemolytic-anaemia (AIHA), 1 polymyositis, 1 polyglandular syndrome and 1 Anti-phospholipid syndrome. The IFA-IgG reactivity of ≥ 1:128 was noted in 14/38 (37%); IFA-IgG-SFG in 7, IFA-IgG-OT in 3 and for both in 4. Of the 14; titre of 1:128 in 2, 1:256 in 4, 1:512 in 5, >1: 1024 in 3 and 8/14 (57%) were SLE, 3/14 (21.4%%) were ITP, 2/14 (14.3%) were AIHA, 1/14 (7.1%) were polymyositis and none were thyroiditis. 8/14 had received anti-rickettsial antibiotics during the early stages of illness based on the clinical presentation and high IFA-IgG titres. CONCLUSION: There was a significant reactivity of Rickettsial disease IFA-IgG assay in auto-immune diseases. Further studies are needed in order to ascertain whether this is due to recent rickettsial infections, false positive cross reactivity of autoimmune antibodies with rickettsial antigens or with cell culture nuclear antigens. We did not carry out IFA-IgM due to non-availability and non-affordability.
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