Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

Background: In this study, we aimed to evaluate the effects of tocilizumab in adult patients admitted to hospital with COVID-19 with both hypoxia and systemic inflammation. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. Those trial participants with hypoxia (oxygen saturation <92% on air or requiring oxygen therapy) and evidence of systemic inflammation (C-reactive protein ≥75 mg/L) were eligible for random assignment in a 1:1 ratio to usual standard of care alone versus usual standard of care plus tocilizumab at a dose of 400 mg–800 mg (depending on weight) given intravenously. A second dose could be given 12–24 h later if the patient's condition had not improved. The primary outcome was 28-day mortality, assessed in the intention-to-treat population. The trial is registered with ISRCTN (50189673) and ClinicalTrials.gov (NCT04381936). Findings: Between April 23, 2020, and Jan 24, 2021, 4116 adults of 21 550 patients enrolled into the RECOVERY trial were included in the assessment of tocilizumab, including 3385 (82%) patients receiving systemic corticosteroids. Overall, 621 (31%) of the 2022 patients allocated tocilizumab and 729 (35%) of the 2094 patients allocated to usual care died within 28 days (rate ratio 0·85; 95% CI 0·76–0·94; p=0·0028). Consistent results were seen in all prespecified subgroups of patients, including those receiving systemic corticosteroids. Patients allocated to tocilizumab were more likely to be discharged from hospital within 28 days (57% vs 50%; rate ratio 1·22; 1·12–1·33; p<0·0001). Among those not receiving invasive mechanical ventilation at baseline, patients allocated tocilizumab were less likely to reach the composite endpoint of invasive mechanical ventilation or death (35% vs 42%; risk ratio 0·84; 95% CI 0·77–0·92; p<0·0001). Interpretation: In hospitalised COVID-19 patients with hypoxia and systemic inflammation, tocilizumab improved survival and other clinical outcomes. These benefits were seen regardless of the amount of respiratory support and were additional to the benefits of systemic corticosteroids. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Convalescent plasma in patients admitted to hospital with COVID-19 (RECOVERY): a randomised controlled, open-label, platform trial

Background: Many patients with COVID-19 have been treated with plasma containing anti-SARS-CoV-2 antibodies. We aimed to evaluate the safety and efficacy of convalescent plasma therapy in patients admitted to hospital with COVID-19. Methods: This randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) is assessing several possible treatments in patients hospitalised with COVID-19 in the UK. The trial is underway at 177 NHS hospitals from across the UK. Eligible and consenting patients were randomly assigned (1:1) to receive either usual care alone (usual care group) or usual care plus high-titre convalescent plasma (convalescent plasma group). The primary outcome was 28-day mortality, analysed on an intention-to-treat basis. The trial is registered with ISRCTN, 50189673, and ClinicalTrials.gov, NCT04381936. Findings: Between May 28, 2020, and Jan 15, 2021, 11558 (71%) of 16287 patients enrolled in RECOVERY were eligible to receive convalescent plasma and were assigned to either the convalescent plasma group or the usual care group. There was no significant difference in 28-day mortality between the two groups: 1399 (24%) of 5795 patients in the convalescent plasma group and 1408 (24%) of 5763 patients in the usual care group died within 28 days (rate ratio 1·00, 95% CI 0·93–1·07; p=0·95). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (3832 [66%] patients in the convalescent plasma group vs 3822 [66%] patients in the usual care group; rate ratio 0·99, 95% CI 0·94–1·03; p=0·57). Among those not on invasive mechanical ventilation at randomisation, there was no significant difference in the proportion of patients meeting the composite endpoint of progression to invasive mechanical ventilation or death (1568 [29%] of 5493 patients in the convalescent plasma group vs 1568 [29%] of 5448 patients in the usual care group; rate ratio 0·99, 95% CI 0·93–1·05; p=0·79). Interpretation: In patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes. Funding: UK Research and Innovation (Medical Research Council) and National Institute of Health Research

Ectopic Pregnancy in Lagos State University Teaching Hospital. Ikeja, Lagos .Nigeria

We set out to determine the socio-demographic factors,pattern of presentation and management of ectopic pregnancy in a University Teaching Hospital in Lagos, Nigeria. A retrospective descriptive analysis of all cases of ectopic pregnancy over a 2-year period was carried out. The case notes were retrieved from the Records Department and the following information extracted; age, parity, clinical presentation, findings at laparatomy, estimated blood loss and the need for blood transfusion. Statistical analysis was done using Epi-info 3.5 statistical software (2008 version). The incidence during the period of study was 38.85/1000 live births.The mean age at presentation was 29.5 _ + 5.7 year(SD) and 124 patients constituting 30.1% were nulliparous .Presentation was usually late with rupture and haemoperitoneum as demonstrated by the large percentage (99.2%). Ampullary part of the fallopian tube was most commonly affected accounting for 360(87.6%) of the cases. Salpingectomy was done in majority of cases - 376(91.3%), while 181 (44%) did not require blood transfusion. There were 3 maternal deaths during the study period..Ectopic presents a major public health challenge among women of reproductive age group in Nigeria. Efforts should be directed to public awareness on sex education , contraception , prevention and treatment of common risk factors for ectopic pregnancy and in cases of early rupture, auto-tansfusion should be encouraged.Key words: Ectopic pregnancy, Factors, Operatio

Hematological profile of normal pregnant women in Lagos, Nigeria

Background: Hematological profile is considered one of the factors affecting pregnancy and its outcome. Anemia is the most common hematological problem in pregnancy, followed by thrombocytopenia. Leukocytosis is almost always associated with pregnancy. The study reported here was designed to evaluate the overall mean values of seven major hematological parameters and their mean values at different trimesters of pregnancy. Subjects and methods: This examination was a cross-sectional study of 274 pregnant women who registered to attend the Lagos University Teaching Hospital or Lagos State University Teaching Hospital antenatal clinics between their first and third trimester. Blood (4.5 mL) was collected from each participant into a tube containing the anticoagulant ethylenediaminetetraacetic acid (EDTA). A full blood count was performed on each sample and the results were analyzed. Results: Overall, the values obtained were (mean ± standard deviation [SD]): hematocrit level, 30.16% ± 5.55%; hemoglobin concentration, 10.94 ± 1.86 g/dL; white blood cells, 7.81 ± 2.34 × 109; platelets, 228.29 ± 65.6 × 109; cell volume 78.30 ± 5.70 fL, corpuscular hemoglobin, 28.57 ± 2.48 pg; and corpuscular hemoglobin concentration, 36.45 ± 1.10 g/dL. When grouped by trimester, the mean ± SD value of packed cell volume at first trimester was 32.07% ± 6.80%; of second trimester, 29.76% ± 5.21%; and of third, 33.04% ± 3.88%. The mean ± SD hemoglobin concentration values were 11.59 ± 2.35 g/dL, 10.81 ± 1.72 g/dL, and 10.38 ± 1.27 g/dL for women in their first, second, and third trimester, respectively. Mean ± SD white blood cell concentration for first, second, and third trimesters were 7.31 ± 2.38 × 109, 7.88 ± 2.33 × 109, and 8.37 ± 2.15 × 109, respectively, while the mean ± SD platelet values for first, second, and third trimesters were 231.50 ± 79.10 × 109, 227.57 ± 63 × 109, and 200.82 ± 94.42 × 109, respectively. A statistically significant relationship was found to exist between packed cell volume and white blood cell count with increase in gestational age (P = 0.010 and 0.001, respectively). However, there was no statistically significant association between platelet count and increase in gestational age (P = 0.296). Conclusion: These findings reinforce the need for supplementation and provide additional information on hematological reference values in pregnancy in Nigeria

Cluster of differentiation 4+ cell count mean value, reference range and its influencing factors in Human Immunodeficiency Virus-seronegative pregnant women in Lagos

Background: Immunity in pregnancy is physiologically compromised and this may affect cluster of differentiation four (CD4) count levels. It is well established that several factors affect CD4 count level in pregnancy. This study aims to determine the effects of maternal age, gestational age, parity and level of education as they influence CD4 count in pregnancy and also to determine the mean and reference range of CD4 count in pregnancy in Lagos, Nigeria. Materials and Methods: A descriptive cross-sectional study was carried out at Ante-natal clinics in Lagos State, Nigeria. About 5 mls of blood was collected into Ethylene Diamine Tetracetic Acid (EDTA) bottles from HIV-negative pregnant women in various gestational ages of pregnancy. CD4+ cell count and full blood count of all samples were done within 3 hours of collection. The descriptive data was given as means ± standard deviation (SD). Pearson's chi-squared test and correlation were used for analytical assessment. Results: A total of 74 pregnant women were recruited. The age range was 19-41 years and a mean age of 30.42 ± 5.34 years. The CD4+ cell count was not statistically significant when compared with participants ages P = 0.417, neither with gestational ages P = 0.323, nor with parity P = 0.247 nor level of education P = 0.96. An overall mean CD4+ cell count was 771.96 ± 250 cells/μl and the range was 193-1370 cells/μl. Conclusion: Maternal age, gestational age, parity and level of education had no significant effects on CD4+ cell count levels in pregnancy. The mean CD4+ cell count of HIV-negative pregnant women in Lagos is 771.96 ± 250 cells/μl

The changing pattern of obstructed labour in Lagos

Background: Obstructed labour is still a major cause of maternal mortality and morbidity and of adverse perinatal outcome in developing countries.Objectives: To determine the incidence, pattern of presentation, source of referral, complications, maternal and perinatal mortality and morbidity from obstructed labour as seen in a university teaching hospital.Methods: A longitudinal descriptive study of all cases of obstructed labour managed at Ayinke House; the Obstetric and Gynecology unit of the Lagos State University Teaching Hospital (LASUTH) Ikeja, between January 2007 and December 2008 was carried outResults: There were 7,470 deliveries during the study period and 316 of these were complicated by obstructed labour giving an incidence of 4.2%. Of the 316 women, 189 (59.8%) were nullipara. One hundred and eleven cases (35.1%) with obstructed labour were booked in LASUTH, while the remainder were unbooked. Cephalopelvic disproportion was the commonest cause of obstruction and accounted for 69.6% of cases and lower segment cesarean section was the most common intervention. Most of the women (42.4%) were in occupational social class IV. The leading complication of obstructed labour was wound infection/ puerperal sepsis accounting for 18.7% of cases There were 15(4.7%) maternal deaths giving a maternal mortality ratio of 1,415 /100,000 and perinatal mortality was 19.9%.Conclusion: Obstructed labour remains one of the leading causes of maternal mortality in this centre with majority being booked for antenatal care.Keywords: obstructed labour, new trend, maternal morbidity and mortalit

Anti-protozoan activities of Harungana madagascariensis stem bark extract on trichomonas and malaria

AIM OF THE STUDY: The ethanolic stem bark extract of Harungana madagascariensis (Hypericaceae), (Choisy) Poir were evaluated for their activities on Trichomonas gallinae (Rivolta) Stabler isolated from the pigeon (Columba livia). It was also tested for their anti-malarial activity on N67 Plasmodium yoelii nigeriensis (in vivo) in mice and on Plasmodium falciparum isolates in vitro. MATERIALS AND METHODS: The anti-trichomonal screening was performed in vitro using Trichomonas gallinae culture. The minimum lethal concentration (MLC) is the lowest concentration of the test extract in which no motile organisms were observed. The anti-malarial effects were determined in-vivo for suppressive, curative and prophylactic activities in mice receiving a standard inoculum size of 1 × 107 (0.2 ml) infected erythrocytes of Plasmodium yoelii nigeriensis intraperitoneally, and the in vitro was performed against 3 isolates of Plasmodium falciparum in a candle jar procedures. RESULTS: The IC50 of the extract and metronidazole (MDZ) (Flagyl) on Trichomonas gallinae at 48 h are 187 and 1.56 μg/ml. The IC50 of the extract, chloroquine (CQ) and artemether (ART) on Plasmodium falciparum are between 0.052 and 0.517 μg/ml for the extract and 0.021 and 0.0412 μg/ml for ART and CQ, respectively. The actions of the extract in in vivo study on Plasmodium yoelii nigeriensis showed that in both suppressive and prophylactic tests the percentages chemo-suppressive were between 28.6–44.8% and 30.2–78.2% respectively, while only 80 mg/kg of the extract reduced the parasitaemia level when compared to the control and the standard drugs in curative test. CONCLUSIONS: Harungana madagascariensis stem bark extract therefore exhibited significant anti-protozoan effects against Trichomonas and Plasmodium both in vivo and in vitro