COVID19

Coronavirus Infection

Pregnancy Disease

Severe Acute Respiratory Syndrome

Instituto Materno Infantil Prof. Fernando Figueira

Northeast COVID-19 and Pregnancy Study Group

Clinical and Laboratory Predictors of COVID-19 Progression and Maternal and Perinatal Outcomes in Infected Pregnant and Postpartum Women in Six Reference Centers in the Northeast of Brazil

Refers to a woman who almost died, but survived a serious complication that occurred during pregnancy, childbirth or within 42 days after termination of the pregnancy, depending on the presence of at least one of the criteria adopted by the World Health Organization ( WHO). Variable, categorical and dichotomous yes / no type.

It is the death of a woman during pregnancy or within 42 days after the end of the pregnancy or due to measures taken in relation to the pregnancy, but not due to accidental or incidental causes. Variable, categorical and dichotomous yes / no type.

It refers to the newborn classified with severe morbidity by pragmatic criteria (Apgar <7 in the 5th minute, birth weight <1,750 grams or gestational age <33 weeks) or conduct (parenteral antibiotic therapy - up to 7 days and before the 28th day of life, nasal CPAP, intubation, up to 7 days and before the 28th day of life, phototherapy within 24 hours of life, cardiopulmonary resuscitation, use of vasoactive drugs, use of anticonvulsants, use of blood products, use of corticosteroids to treat refractory hypoglycemia and surgery) but who survived the 27th day of life, included. Yes / no categorical and dichotomous variable.

Death occurred in the first 27 days, included, after delivery. Yes / no categorical and dichotomous variable.

Death occurred in the first 7 days of life. Yes / no dichotomous categorical variable

Intrauterine death, corresponding to the birth of a fetus without signs of life, weighing 500 grams or more. Dichotomous categorical variable of the yes / no type.

Corresponds to cases of fetal death added to those of early neonatal death. Dichotomous categorical variable of the yes / no type.

Calculated based on the date of birth recorded in the medical record, hospital identification data, or according to the patient's information, in full years. Numerical and discrete variable.

maternal weight before pregnancy, in kilogram (kg), according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

expressed, in meters, according to information collected from the patient and / or made available on the prenatal card or medical record. Numeric and continuous variable.

classified according to pre-gestational BMI: low weight grade III (≤ 16.00), low weight grade II (≥ 16.00 to <16.99), low weight grade I (≥ 17 , 00 to <18.49), ideal weight (≥ 18.50 to <24.99), overweight (≥ 25.00 to <29.99), grade I obesity (≥ 30.00 to <34.99) , grade II obesity (≥35.00 to <39.99) and grade III obesity (≥ 40.00).

expressed in Kg / m2, calculated by weight (kg) divided by height (m) squared. Numeric and continuous variable.

according to the patient's self-declaration and collected according to information and / or recorded in the medical record or prenatal card in black, white, brown, yellow and indigenous.

defined as the number of people, regardless of age, living in the same household, collected according to the patient's information. Numerical and discrete variable.

collected according to the patient's information as the sum of the monthly income of all members living in the household, including benefits from social programs and informal income. Categorized in: up to 1 minimum wage; 1 to 2 minimum wages; 3 to 5 minimum wages; more than 5 minimum wages. Numerical and discrete variable.

as informed by the patient, recorded in medical records or prenatal card and categorized as illiterate (zero), elementary school (one to nine years), high school (10 to 12 years) and higher education (> 12 years) ). Numerical and discrete variable.

as declared by the patient and noted on the medical record or prenatal card, later categorized as: health, education, general services, home, domestic, student, merchant or commerce, security, self-employed, economy, tourism, music, nutrition, computers, journalism, engineering and others.

as declared by the patient, as being a formal job or not, which presents any monthly financial income. Yes / no categorical and dichotomous variable.

declared by the patient and recorded in medical records or prenatal card in: single, married, stable, separated and widowed.

as informed by the patient and recorded in medical records, related to the city where she lives, defined as Recife, metropolitan region (Jaboatão dos Guararapes, Olinda, Paulista, Moreno, Igarassu, Abreu e Lima, Camaragibe, Cabo de Santo Agostinho, São Lourenço da Mata, Araçoiaba, Itamaracá Island, Ipojuca and Itapissuma), interior and other states.

according to the belief declared by the patient and categorized into: atheist, catholic, evangelical, spiritist, Anglican charismatic and others.

smoking, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

habit of drinking alcoholic beverages, regardless of quantity, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

use of non-legal drugs, such as marijuana, cocaine, crack and the like, regardless of the amount, during pregnancy, as stated by the patient. Yes / no categorical and dichotomous variable.

number of previous pregnancies, including the current one, regardless of the gestational outcome (abortion, delivery, number of fetuses, ectopic pregnancy or fetal death), as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous deliveries with fetuses over 500g and / or gestational age greater than 22 weeks, regardless of multiple gestation, perinatal death or delivery, as reported by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous deliveries with fetuses over 500g and / or gestational age greater than the 22nd week, by cesarean section, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of previous births with fetuses above 500g and / or gestational age greater than 22 weeks, vaginally, regardless of whether instrumental, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of interruptions of pregnancy with fetuses below 500g and / or gestational age below 22 weeks, regardless of being spontaneous, as informed by the patient and noted in the medical record or prenatal card. Numerical and discrete variable.

number of children who remain alive, regardless of the cause of death, as informed by the patient and noted in medical records or prenatal card. Numerical and discrete variable.

as informed by the patient or noted on the prenatal card and medical record, the number of consultations performed during prenatal care. Numerical and discrete variable.

gestational age, in weeks, calculated by the day of the last menstruation and confirmed by the first ultrasound scan of the onset of flu-like signs and symptoms. Numerical and discrete variable.

number of days after birth of the onset of flu-like signs and symptoms. Numerical and discrete variable.

number of days the patient had signs and symptoms of flu-like syndrome and its complications. Numerical and discrete variable.

when the patient declared that at the beginning of the signs and symptoms she was separated / isolated at home without any contact with healthy people, including not even going out for essential purchases, for a period of 14 days. Yes / No categorical and dichotomous variable.

it is a measure of community restraint, adopted in some cases, to prevent the spread of a certain contagious disease. Considered when the patient declared that she was at home, leaving only what was necessary for essential purchases, before the onset of signs and symptoms. Yes / No categorical and dichotomous variable.

when the patient declared that she had contact with people infected with COVID-19 and / or traveled to places considered to be the epicenter of the disease, but even asymptomatic, she stayed home without contact with other people, including not even going out for essential purchases, for a period of seven to 14 days. Yes / No categorical and dichotomous variable.

when there is a need for hospitalization due to flu-like syndrome and / or its complications, excluding hospitalizations due to obstetric complications and includes all participants, especially pregnant women monitored during prenatal care. Yes / No categorical and dichotomous variable.

day of hospitalization due to flu syndrome and / or complications. Numerical and discrete variable.

length of stay, in days, as described in the medical record. Numerical and discrete variable.

As reported by the patient (dry cough, day of onset of dry cough, productive cough, day of onset of productive cough, coryza, day of onset of runny nose, body pain, day of onset of body pain, abdominal pain, day of onset of abdominal pain, chest pain, day of onset of chest pain, headache, day of onset of headache, dyspnoea, day of onset of dyspnoea, subfebrile state, day of onset of subfebrile state, fever, day of onset of fever, diarrhea , day of onset of diarrhea, sore throat, day of onset of sore throat, taste change, day of onset of taste change, smell change, day of onset of smell change, asthenia, day of onset of asthenia , axillary temperature, oxygen saturation).

result of RT-PCR in the diagnosis of COVID-19, by means of blood or nasopharyngeal secretion, according to the usual technique, being categorized as positive, negative and indeterminate.

result of RT-PCR in the differential diagnosis of respiratory syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, being categorized as positive (any virus found), negative and indeterminate.

result of the RT-PCR of the viral panel in the differential diagnosis of flu syndrome, through blood or nasopharyngeal secretion, according to the technique and kit used, categorized according to the virus found.

result in the diagnosis of COVID-19, by means of blood, according to the usual technique, being categorized as positive, negative and indeterminate.

result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 5th day of signs and symptoms. Numeric and continuous variable.

result of IgG COVID-19 serology, by means of blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit, performed after 14th day of signs and symptoms. Numeric and continuous variable.

rom the first exam (day zero). Describe the subsequent days. Numerical and discrete variable.

after diagnostic confirmation of COVID-19 and 14 days after the cure criteria, the RT-PCR test returns positive. Yes / No categorical and dichotomous variable.

substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A, IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, from the beginning of the flu syndrome or COVID- 19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

day of the first cytokine dosage from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

day of the first blood count from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first hemoglobin measured in maternal blood, in g / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 11.0g / dL and ≤ 16.0g / dL. Numeric and continuous variable.

value of the first leukocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 4,000 / mm3 and ≤ 11,000 / mm3. Numerical and discrete variable.

when the rod / segment ratio is greater than 1/16 and / or the presence of young cells (promyelocytes, myelocytes, metamyelocytes) occurs, starting with the flu syndrome and in the period of the syndrome. Yes / No categorical and dichotomous variable.

value of the first platelet measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 150,000 / mm3 and ≤ 400,000 / mm3. Numerical and discrete variable.

value of the first typical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 1,050 / mm3 and ≤ 3,850 / mm3. Numerical and discrete variable.

value of the first atypical lymphocyte measured in maternal blood, / mm3, from the flu syndrome and in the period of the syndrome, being normal ≥ 0 / mm3 and ≤ 220 / mm3. Numerical and discrete variable.

day of the first coagulogram from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first TB measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, being normal from 60s to 180s. Numerical and discrete variable.

value of the first CT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

value of the first TD measured in maternal blood, in seconds (s), from the flu syndrome and in the period of the syndrome, with a value of up to 11.3s being normal. Numerical and discrete variable.

value of the first APTT measured in maternal blood, in seconds (s), from the flu syndrome and the period of the syndrome, with a value of up to 30.5s being normal.

value of the first INR measured in maternal blood, from the flu syndrome and the period of the syndrome, being normal between 2 and 3. Numerical and discrete variable.

day of the first urea from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

day of the first creatinine from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numerical and discrete variable.

defined as aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP), from the beginning of the flu syndrome or COVID-19 on syndrome period.

day of the first VSH from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first VSH measured in maternal blood, in mm / h, from the flu syndrome and in the period of the syndrome, being normal <20mm / h. Numerical and discrete variable.

day of the first CRP from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first CRP measured in maternal blood, in mg / L, from the flu syndrome and in the period of the syndrome, being normal <5mg / L. Numerical and discrete variable.

day of the first D-dimer from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first D-dimer dosed in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

day of the first DHL from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first DHL measured in maternal blood, in mg / dL, from the flu syndrome and the period of the syndrome, being normal ≥ 125U / L and ≤ 243U / L. Numerical and discrete variable.

day of the first alkaline phosphatase from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first alkaline phosphatase measured in maternal blood, in U / L, from the flu syndrome and in the period of the syndrome, being normal ≥ 46U / L and ≤ 116U / L. Numerical and discrete variable.

day of the first troponin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the first troponin measured in maternal blood, in ng / mL, from the flu syndrome and in the period of the syndrome, being normal <0.4 ng / mL. Numerical and discrete variable.

day of the first ferritin from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

alue of the first ferritin measured in maternal blood, in ng / mL, from the flu syndrome and the period of the syndrome. Numerical and discrete variable.

defined as total (BT), direct (BD) and indirect (BI) bilirubins from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome.

day of the first blood culture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

result of the first blood culture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

name of the microorganism, which grew on examination, from the flu syndrome and the period of the syndrome, according to its taxonomic classification.

day of the first uroculture from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

result of the first uroculture from the flu syndrome and in the period of the syndrome, categorized as negative and positive (growth of the microorganism). Categorical and dichotomous variable.

worst result of IgM COVID-19 serology, through blood, according to the Enzyme-Linked Immunosorbent Assay (ELISA) technique or immunochromatography or chemiluminescent immunoassay, being categorized as positive, negative and indeterminate, of according to the reference values of each serological kit, performed after the 5th day of signs and symptoms. Numeric and continuous variable.

Result of the worst result of IgA COVID-19 serology, through blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each serological kit , performed after the 5th day of signs and symptoms. Numeric and continuous variable.

worst result of IgG COVID-19 serology, performed using blood, according to the ELISA technique, being categorized as positive, negative and indeterminate, according to the reference values of each kit serological test, performed after the 14th day of signs and symptoms. Numeric and continuous variable.

substances capable of modulating the cellular response of several cells, such as interleukins - IL-1ra, IL-6, IL-2, IL-5, IL-10, IL-12, IL-13, IL17A , IL-4, IL-1β, IL-9, IL-15, Interferon - IFN-γ and Tumor necrosis factor - TNF-α, in maternal blood, in pg / ml, being the worst maternal result, from the beginning of the flu syndrome or COVID-19 and in the period of the syndrome. Numeric and continuous variable (for each cytokine).

day of the performance of the worst urea result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the worst result of urea measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome being normal ≥ 19.2mg / dL and ≤ 49.2mg / dL. Numerical and discrete variable.

day of the worst creatinine result from the flu syndrome and in the period of the syndrome. Numerical and discrete variable.

value of the worst result of creatinine measured in maternal blood, in mg / dL, from the flu syndrome and in the period of the syndrome, being normal ≥ 0.5mg / dL and ≤ 1.1mg / dl. Numeric and discrete variable.

defined as the worst outcome of aspartate aminotransferase (AST) or glutamic-oxalacetic transaminase (TGO) and alanine aminotransferase (ALT) or glutamic-pyruvic transaminase (TGP) from the onset of the flu syndrome or COVID- 19 and in the period of the syndrome.

Leila Katz

Principal Investigator

Dietary supplement : Lit-Control® pH Down
Pharmaceutical form: capsules
Administration : oral
Dose: 3 capsules/day.
• Sanitary product : Lit-Control® pH Meter
In vitro diagnosis sanitary product
Use:Urinary pH evaluation

Placebo:
Pharmaceutical form: capsules
Administration : oral
Dose: 3 capsules/day.
• Sanitary product : Lit-Control® pH Meter
In vitro diagnosis sanitary product
Use:Urinary pH evaluation

Stent Complications

Patients within the experimental arm will receive dietary supplement Lit-control®pH Down to help them keep their urinary pH in the adequate levels, being these considered as the preventive ones to avoid stent calcification (pH<6.2) being the 3 capsule per day indication. On the other hand, the control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics. Both arms wil use Lit-Control® pH Meter device to keep self- control of the urinary pH; also, both will receive the same hygienic-dietary indications about the care of the stent.

Lit control pHDown

Hospital Universitario de Valme

Hospital Universitari de Bellvitge

Complejo Hospitalario Universitario de Santiago de Compostela

Hospital Álvaro Cunqueiro

Fundació Puigvert

Hospital Clínico Universitario San Cecilio

Hospital Universitario La Paz

Hospital Universitari i Politècnic La Fe

Hospital Universitario Rio Hortega

Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.

Multicenter, Controlled and Randomized Clinical Trial to Evaluate the Combined Use of a Medical Device and a Food Supplement in the Control of Urinary pH in Patients With an Implanted Double Pigtail Stent

0 (No incrustation); 1(Sporadic incrustation less than 1-2 mm); 2 (Wide area calcifications more than 1-2 mm) ; 3 (Total obstruction)

Medical evaluation and diagnosis leading to stent implant

Medical evaluation on the different alterations present in the urinary system.

Number of obstructions in the past two months.

The clinical will evaluate the patient treatment adherence by means of Morisky-Green test

Possibility of complications during the extraction, date of extraction, intervention type, intervention duration

Different symptomatology associated with the previous calcification

Devicare S.L.

Clever Instruments S.L.

Adults attending urology/nephrology consultation whom have been recently implanted a double J stent or have its implantation programmed and are able of taking care in urinary pH self-control.

5 mg prednisolone per os daily administration

The placebo is designed to the equal look like the study medication.

HIV Disease Progression

Prednisolone

Bugando Medical Center

Progression of HIV-Disease Under Low Dose Corticosteroids

A Phase II Clinical Trial to Assess Risk and Benefit of Oral Low Dose Prednisolone for HIV Infected People Prior to the Commencement of Antiretroviral Treatment

The primary objective of the study is to assess the effect of the low dose prednisolone therapy on the time to progression of HIV disease. The time to progression is defined as the time between the baseline and the change of staging to advanced disease (CDC stage A3, B3 or C) or death

The total CD4 cell count, measured in number of cells per µl, should be significantly higher in the intervention group.

The rate of survival should not differ significantly between the two groups.

The quality of life of participants, as measured by a standardised set of questions, should not differ significantly between the two groups.

The rate of co-infections should not be significantly higher in the intervention group.

In vitro studies on isolated lymphocytes of patients in both arms should show significant differences in their activation status.

urinary tract infections/phosphatase

Northeast COVID-19 and Pregnancy Study Group

Combined Use of a Medical Device and a Dietary Complement in Patient Urinary pH Control in Patients With an Implanted Double J Stent.

Progression of HIV-Disease Under Low Dose Corticosteroids

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